Industry News

                 Specialty Pharma Newsletter (March 2013)

Apr 8     “Childhood Immunization as a Tool to Address Health Disparities.”   This session will be available via live webcast from CDC headquarters in Atlanta, Georgia on Tuesday, April 16 at 1 p.m. (EDT) at http://www.cdc.gov/about/grand-rounds/.   This session of Grand Rounds will examine how immunization has helped reduce infectious disease disparities among U.S. children, reducing infectious disease burdens in children from racial/ethnic populations, and how immunization has, as a result, contributed to health equity.

Apr 4     Public Notifications “Ninja Mojo”, “Love Rider” and “Affirm XL” contain hidden drug ingredient.

               All contain either tadalafil which is the active ingredient in Cialis or sildenafil which is the active ingredient in Viagra.  This undeclared may interact with nitrates which are found in some prescription drugs, such as nitroglycerin.  This interaction may lower blood pressure to dangerous levels.

               Ninja Mojo was distributed by Ninja America Inc., College Point, NY.   Love Rider” was distributed by Nutratech, Inc., Woodbridge, VA.  “Affirm XL was distributed by Affirm XL, LLC, Ladera Beach, CA (made in Korea).

Apr 3     Recalls – Class II

               Ciprofloxacin Tablets, USP, 500 mg, manufactured for West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan (NDC 01439928-01).  This product is being recalled due to the presence of foreign material (rubber-like material).

Apr 3     Guidance for Industry

               CDER List of Guidance Documents can be viewed/downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery

               CDER List of New/Revised/Withdrawn Guidance (January 1, 2013 to April 1, 2013) can be viewed/downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM254636.pdf?source=govdelivery

               Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format can be viewed/downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346564.pdf?source=govdelivery

Apr 2     Nicotine Replacement Therapy (NRT) Labels May Change.   FDA, after reviewing scientific research on the safety of NRT products sold over the counter (OTC)—has decided that some warnings and limitations specified in the directions for use on the labels of these products are no longer necessary to make sure they are used safely and effectively to quit smoking.  You can learn more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm345087.htm?source=govdelivery                 

Apr 2     Change of Address; Biologics License Applications.  FDA is amending CFR 600.2(b) to update the address for applicants to submit BLAs and BLA amendments and supplements regulated by CDER. The new address for all these submissions is CDER Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901B Ammendale Rd., Beltsville, MD 20705. This action is being taken to ensure accuracy and clarity in the Agency's regulations.  The federal register notice is available at:  https://www.federalregister.gov/articles/2013/04/02/2013-07578/change-of-address-biologics-license-applications-technical-amendment?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Apr 2    Draft Guidance for Industry                                                                                                               Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants.  This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the CDER and CBER. The guidance assists sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf?source=govdelivery

               Formal Dispute Resolution: Appeals Above the Division Level.  This guidance is intended to provide recommendations for industry on the procedures in CDER and CBER for resolving scientific and procedural disputes that cannot be resolved at the division level. This guidance describes procedures for formally appealing such disputes to the office or center level and providing information to assist FDA officials in resolving the issue(s) presented. This guidance revises the guidance of the same name issued in February 2000.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM343101.pdf?source=govdelivery

Apr 2     Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation.  This guidance provides recommendations to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding what criteria should be met when evaluating and labeling tablets that have been scored. (A scoring feature facilitates tablet splitting, which is the practice of breaking or cutting a higher-strength tablet into smaller portions.) Specifically, this guidance recommends guidelines to follow, data to provide, and criteria to meet and detail in an application to support approval of a scored tablet; and nomenclature and labeling for approved scored tablets.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269921.pdf?source=govdelivery

Apr 1     The Electronic Drug Registration and Listing Instructions have been updated.  This and related links can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm?source=govdelivery

Apr 1     Guidance for Industry

               SUPAC: Manufacturing Equipment Addendum.  You can read or download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM346049.pdf?source=govdelivery

Mar 29   FDA approves Invokana to treat type 2 diabetes.   First in a new class of diabetes drugs.  The U.S. Food and Drug Administration today approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.  Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.  Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.  Caution: new drugs in a new class of drugs may exhibit previously unknown side effects during their first five years on the market.

Mar 27   Recalls – Drugs Class III

               Carisprodol Tablets, USP 350 mg Rx Only manufactured by West-Ward Pharmaceuticals, Eatontown, NJ.    This product is being recalled because this product was recently reclassified in June 2012 as C-IV, and it was not relabeled with the required “C-IV” imprint after that date.

 Mar 27   Recalls – Drugs Class II

               Meprobamate Tablets, USP, 400 mg and 200 mg, Rx Only manufactured by Watson Laboratories, Inc., Corona, CA 92800.   These products are being recalled because they failed impurities/degradation – out of specification result for the impurity diphenyl sulfone.

               Zarah Drospirenone/Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg Rx Only, manufactured by Watson Laboratories, Inc., Corona, CA 92800.  This product is being recalled because it failed specification - tablets break when pushed through blister pack.

Mar 25   TOBI Podhaler (tobramycin inhalation powder) has been approved for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.  Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with cystic fibrosis are treated with antibiotics using a nebulizer machine.  TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.

Mar 22  Warning Letter

               Issued to Asada Milling Company, Ltd, Gunma, Japan 370-2202.  During inspection in October 2012 significant deviations from current Good Manufacturing Practice for the manufacture of active pharmaceutical ingredients (APIs) were identified.  Among them were failure to follow written procedures, failure to maintain and clean manufacturing equipment and facilities, and failure to establish written procedures pertaining to handling of raw materials used in API production and failure to establish specifications for finished API release, failure to prepare adequate batch production records and failure to identify produced batches with a unique batch identification number.     

Mar 19   Recalls – Class II

               Clinical Specialties is voluntarily recalling Avastin unit dose syringes.  The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.  This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes.

Mar 18   FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey.  The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting, Inc., Tinton Falls, N.J., a specialty pharmacy licensed by the state of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.  Giving a patient a contaminated injectable drug can result in a life-threatening infection.  In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.

Mar 15   Drug Shortages                                                                                                                                 Rifamate capsules containing 300 mg rifampin and 150 mg isoniazid
(NDC 0068-0509-60)  manufactured by Sanofi-aventis U.S. LLC., will not be available until July 2013 due to manufacturing delays.  

               Levothyroxine sodium (Levoxyl) tablets in the 50 mcg through 200 mcg strengths are currently on back order by Pfizer.

Mar 15   FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes.  The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes.  FDA recommends that at this time, patients should (at their own risk) continue to take their medicine as directed until they talk to their health care professional, and health care professionals to make a determination to or not to continue to follow the prescribing recommendations in the drug labels.  

 Mar 14   The Cumulative Supplement 2 (February 2013) for the Approved Drug Products (The Orange Book) is now available for download:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf?source=govdelivery 

               Orange Book Data Files (compressed) (ZIP 549KB) can be found at:  http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwMzE1LjE2NzEwNTMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDMxNS4xNjcxMDUzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MDU0NTQ1JmVtYWlsaWQ9cmVndWxhdG9yeW5ld3NAZ21haWwuY29tJnVzZXJpZD1yZWd1bGF0b3J5bmV3c0BnbWFpbC5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&108&&&http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM163762.zip?source=govdelivery

Mar 14   FDA/CDER Small Business Chronicles for March is entitled “Enrichment Strategies”.  You can download/read a copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM343794.pdf?source=govdelivery 

               Previous issues of Small Business Chronicles are available at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm299560.htm

 Mar 12   FDA Declares Possibility of Potentially Fatal Irregular Heart Rhythm with Z-PAC Antibiotics Administration.  The FDA has issued a Drug Safety Communication warning the public that azithromycin (brand names: Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially sudden death irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.  FDA released a statement on May 17, 2012, about a New England Journal of Medicine study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin, and levofloxacin, or no antibacterial drug.  The study reported an increase in cardiovascular deaths and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment (1 in 4000 for at risk patients).   

Pharmaceuticals in some form date back to the Middle Ages, but in modern days there are hundreds of prescription and over-the-counter medications available. Not only do humans consume pharmaceuticals, but livestock consumes millions of doses, as well. The global pharmaceutical market continues to grow year by year, and with it environmental concerns pertaining to not just production, but also consumer waste and disposal.

The US Department of Health and Human Services reports that at least half of all Americans take a minimum of one prescription drug, with one in six taking three or more. This doesn’t include the frequent use of over-the-counter medications for easing a headache, such as acetaminophen, aspirin, ibuprofen, naproxen sodium, or one of the many other maladies people suffer from on an occasional basis. Unused medication piles up in many households and waits for its final disposal. But where does it usually end up? Unfortunately, not always in the right place.

Pharmaceutical pollution is created by human activity. Residues come from manufacturing, veterinary use, agribusiness, hospitals, and community use. According to the US Geological Society, non-prescription drugs and steroids were more often detected in streams than prescriptions drugs, though a variety of prescription drugs were also present.

Improperly disposed medications, considered a toxic waste that finds its way into streams and drinking water, negatively impact humans, wildlife, and agriculture. At this time, many unknowns remain regarding the possible adverse effects on ecological receptors and humans from exposure to pharmaceutical pollutants in the environment. However, the possible risk to aquatic organisms due to exposure to these pollutants in the environment has been identified as a primary concern.

For medications intended for discard, pharmacists are expected to comply with a federal law, the Resource Conservation and Recovery Act (RCRA), as well as other regulations, for both hazardous and non-hazardous pharmaceuticals. However, many hospitals, unfortunately, continue to dispose of pharmaceuticals, except chemotherapy agents, by simply throwing them down the drain or sending them to the landfill.

According to the Minnesota Pollution Control Agency, the preferred method for destruction of household pharmaceuticals is incineration. If household garbage goes to an incinerator, medication gets disposed of safely. If household garbage goes to a landfill, it is not preferred over taking them to designated pick up sites, but is still preferable over flushing them down the toilet.

One topic that has not been discussed is pharmaceutical waste that comes from us, people. After taking medications each day, a large percentage of the active ingredients does not metabolize and ends up in human waste. Excess drugs in the bloodstream leave the body through urine and fecal matter, and the excreted chemicals flow with the sewage out of our homes to the streams and lakes. How can we help this form of pollution? Is it possible at this time?

Pharmaceutical Pollution Concern around the World

North America represents approximately 38% of the global pharmaceutical market with Europe following closely. Like in the US, the role of pharmaceuticals in water pollution is being taken as a major concern. The European Commission unveiled a new set of water rules, which for the first time included certain pharmaceutical products. Particular medications, such as pain relieving drug Diclofenac, are on the watch list.

According to Nature, an international weekly journal of science, “Many of Europe’s rivers are home to male fish that are ‘intersex’ and so display female sexual characteristics, including female reproductive anatomy. Some males also produce vitellogenin, a protein normally found in eggs that can be induced in males by hormone exposure. In one of the largest studies of the problem in 2004, the UK government’s Environment Agency found that 86% of male fish sampled at 51 sites around the country were intersex.” Toxicologists blame this feminization on endocrine-disrupting chemicals — particularly the active ingredient in the contraceptive pill, ethynyl oestradiol (EE2). This is a specific example of the pharmaceutical industries effect on the environment.

One very recent case of pharmaceutical pollution by a large company is a recent scandal in China. The Harbin Pharmaceutical Group, a major company in China’s HeiLongJiang province decided to relocate after waste gases and water that exceeded legal pollution limits were released into the environment. They received a steep fine, but other types of penalties have not yet been published.

Drug companies around the world are increasing production of both prescription and non-prescription pharmaceuticals for a growing market. As people continue to increase their intake of medication, so must they increase awareness of pharmaceutical pollution, and hold the health care industry accountable, as well.

Tackling the Problem

Pharmaceutical pollution can be stopped for the most part, but currently there are no commonly used methods of preventing it from human or animal waste. Instead, we must concentrate on ways of proper disposal and actually using them. We meaning consumers, hospital staff, pharmacy staff, scientists, and pharmaceutical companies.

In the United States, many environmental groups, health organizations, police, drugstores, and drug manufacturers participate in drug take-back programs. The only difficulty with these programs is that environmental groups and health organizations are sometimes inconvenient to reach, police may only take the drugs on certain days of the year, and some drugstores in certain states require payment for “envelopes” used for disposal. In addition, controlled substances may not be accepted by anyone other than the police since it is illegal to hand such medications over to someone else. Given this, some people who may normally recycle or properly dispose medication may resort to flushing them down the toilet or throwing them in the garbage for potential roving hands or animal thieves.

Unfortunately, people in many states in the US do not even know about the proper disposal of medications. The communication of proper medication disposal methods varies from state to state. Luckily some states have been successful in gathering unwanted medication. In Washington State alone, more than 75,000 pounds of drugs were returned to such places in 2 years alone.

How SHOULD pharmaceuticals ideally be disposed of? Currently high temperature incineration at suitably permitted facilities is the safest disposal method for toxic leftover medications. This is the method the pharmaceutical industry uses to dispose of their unwanted medicines. As the dangers of pharmaceutical pollution are becoming more and more apparent, awareness of regulatory institutions and pharmaceutical companies rises, as well. With more disposal centers, regulation, and education of the population, many of detrimental impact of pharmaceutical waste might be successfully negated in the near future.

For more information regarding this article, please see link:

http://www.kwikmed.org/environmental-impact-pharmaceutical-industry/

Mar 12   Green Planet, Inc. Issued a Voluntary Nationwide Recall of One Lot of "Night Bullet," a Product Marketed as a Dietary Supplement to Support Male Sexual Performance, Due to Undeclared, Potentially Hazardous Active Ingredients.  “Night Bullet” contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil. Sulfohydroxyhomosildenafil and Aminotadalafil are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED) making this product an unapproved drug.

Mar 11   Guidance For Industry:  Guidance Agenda - New and Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2013.  You can download the list at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf

Mar 11   Drug Shortages                                                                                                                                                        Isoniazid Tablets, Methazolamide Tablets, and Nitroglycerin Ointment USP, 2%

Mar 8     FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex.  The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).  NRL is a milky fluid found in rubber trees and other plant sources. Prolonged or repeated exposure to NRL can result in sensitivity or allergy. Mild reactions may include skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock may occur.  Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm342855.htm

Mar 6     Recalls – Class II

Citalopram Tablets, USP, 10 mg, 20 mg, and 40 mg with NDC numbers 5511-342-30, 5511-343-30 and 5511-344-30, respectively; Dr. Reddy’s Laboratories, Inc.   Reason: Chemical Contamination.  The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

Feb 28    FDA Suspends Pediatric Clinical Trials of Sensipar (Cinacalcet Hydrochloride) after report of death of a 14 year old patient.   FDA has approved Sensipar for use in adults, but not in children less than 18 years of age, and the clinical trials were underway to determine if the drug is effective and can be used safely in children.  You can read more and listen to the podcast at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm341518.htm

Feb 28    Draft Guidance for Industry and Review Staff – Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling.  You can download it at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM341394.pdf?source=govdelivery 

Feb 28    Guidance for Industry - Labeling for Human Prescription Drug and Biological Products; Implementing the Physician Labeling Rule Content and Format Requirements.   This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under 21 CFR 201.56(d) and 201.57. FDA is issuing this guidance to provide recommendations for applicants developing labeling for new prescription drugs and revising labeling for already approved prescription drugs.  You can download the guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf?source=govdelivery  

Feb 28    Documents to Support Submission of an Electronic Common Technical Document.  FDA is announcing the availability of the following revised final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: “The eCTD Backbone Files Specification for Module 1, version 2.1” (which includes the U.S. regional document type definition, version 3.1), and “Comprehensive Table of Contents Headings and Hierarchy, version 2.1.”   To review/download these files go to:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163552.pdf?source=govdelivery

And

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf?source=govdelivery

Feb 28    Guidance on Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data.   The purpose of this attachment is to assist sponsors in submitting hepatitis C virus (HCV) clinical virology data, which are important for supporting clinical trials of products in development for the treatment of HCV. HCV resistance data submitted in appropriately formatted datasets is a critical component in the review of investigational antiviral products for the treatment of HCV. The information in this attachment will facilitate the development and regulatory review of anti-HCV products.   Download Draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM340712.pdf?source=govdelivery 

Feb 28    Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators.  This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators.  Read the Federal Register Notice at:  https://www.federalregister.gov/articles/2013/02/26/2013-04386/guidance-for-clinical-investigators-industry-and-food-and-drug-administration-staff-financial?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov 

Feb 28    The FDA is requesting comments on Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application.  FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).  The Federal Register Notice can be reviewed at:  https://www.federalregister.gov/articles/2013/02/26/2013-04422/agency-information-collection-activities-proposed-collection-comment-request-foreign-clinical?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

 Feb 28    Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products.  FDA is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.   See the Federal Register Notice at:  https://www.federalregister.gov/articles/2013/02/26/2013-04387/additional-safeguards-for-children-in-clinical-investigations-of-food-and-drug?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Feb 26    FDA Approves Osphena for Postmenopausal Women Experiencing Pain During Sexual Intercourse.  Dyspareunia is a condition associated with declining levels of estrogen hormones during menopause. Less estrogen can make vaginal tissues thinner, drier and more fragile, resulting in pain during sexual intercourse.  Osphena, a pill taken with food once daily, acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in the amount of pain women experience with sexual intercourse.           Osphena is marketed by Florham Park, N.J.-based Shionogi, Inc.

Feb 25    FDA approves Stivarga for advanced gastrointestinal stromal tumors.  The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.  Stivarga, a multi-kinase inhibitor, blocks several enzymes that promote cancer growth. With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or has spread to other parts of the body (metastatic) and is no longer responding to Gleevec (imatinib) and Sutent (sunitinib), two other FDA-approved drugs to treat GIST.

Feb 25    Guidance for Industry - Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements.  You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf?source=govdelivery

Feb 22    Warning Letter                                                                                                                                            Issued to Organics Corporation of America (dba Ambix Laboratories) Totowa, NJ 07512.   During inspection serious violations of current Good Manufacturing Practice (cGMP) regulations for dietary supplements were found which cause Baby Plex Vitamin Drops, Carnitine Liquid, and Optimal Nutritional Liquid dietary supplement products to be adultrated.

Feb 21    Discontinued Drugs:   Merck, Sharp & Dome, a subsidiary of Merck and Co., Inc. has permanently discontinued Prinzide (Linsinoprin and Hydrochlorothiazide 10mg/12.5mg and 20mg/12.5mg Tablets).  Generic versions of these products are available from other manufacturers. 

Feb 20    Warning Letter                                                                                                                                        Issued to Jubilant HollisterStier General Partnership, Kirkland Quebec, Canada H9H 4J4.    Current Good Manufacturing Practice (cGMP) violations for sterile products. 

Feb 19    Discontinued Drugs

West-Ward Pharmaceuticals has discontinued the following products:                                                Two strengths of Flurazepam Hydrochloride Tablets (15 mg and 30 mg).                                            Hydrochlorothiazide Tablets USP, 50 mg and 200 mg strengths.                                       Hydroxychloroquine Sulfate Tablets, USP, 200 mg.                                                                               Lithium Carbonate Capsules, USP, 150 mg and 300 mg.                                                                   Naproxen Sodium Tablets, USP, 550 mg.                                                                                        Trihexphenidyl Hydrochloride Tablets, USP, 2 mg.

Feb 14    Warning Letter                                                                                                                                      Issued to Laclede, Inc., Rancho Dominguez, CA 90220.   Numerous violations were uncovered during a recent inspection including violations of current Good Manufacturing Practice (cGMP) regulations as they relate to product conformance testing to specifications (assay), lack of written testing program for stability, and failure to conduct at least one specific identity test on incoming components as well as establishing the reliability of supplier’s analysis.   The inspection revealed that Luvena Prebiotic Vaginal Moisturizer and Lubricant is an unapproved and mis-branded product and two topical fluoride prescription drug products are also unapproved.

Feb 14    Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease.  This draft guidance outlines FDA’s current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer’s disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA’s current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. The selection of outcome measures for trials in these populations that are designed to demonstrate a clinical benefit, as well as the manner in which disease modification might be demonstrated, are also addressed.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf?source=govdelivery  

Feb 14    Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products.  The purpose of this document is to assist manufacturers and clinical investigators involved in the development of therapeutic protein products for human use. The guidance outlines, and recommends adoption of, a risk-based approach to evaluating and mitigating the potential for immunogenicity that may affect the safety and efficacy of therapeutic protein products. The guidance describes various product- and patient-specific factors that can affect the immunogenicity of protein therapeutics and provides recommendations pertaining to each of these factors that may reduce the likelihood that these products will generate an immune response. In addition, the guidance offers a series of recommendations for risk mitigation in the clinical phase of development of protein therapeutics. The draft guidance also provides supplemental information on the diagnosis and management of particular adverse consequences of immune responses to protein therapeutics and contains brief discussions of the uses of animal studies and the conduct of comparative immunogenicity studies.  Read or download the draft guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf?source=govdelivery 

 Feb 13    Enforcement Report

Estee Lauder DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF-15 (UPC 2713179904).  This product failed stability specifications in that the active sunscreen ingredient may not be stable over the shelf life.  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM339381.pdf?source=govdelivery 

Feb 11 Warning Letters

               Internet Marketing of Unapproved Drug (Generic Tamiflu) Warning Letters issued to:  Medsnoscript, Secure Medical, Sun Drug Store, and Discount Online Pharmacy.

               Internet Marketing of Unapproved Drug (Halo on www.halogermdefense.com) Warning Letter issued to Oasis Consumer Healthcare, LLC.

               Internet Marketing of Unapproved Drug (Pirfenidone on www.buy-pharma.com) Warning Letter issued to buypharma.com

Internet Marketing of Unapproved Drug (Pirfenidone on www.bigmountaindrugs.com and on www.buypirfenidone.com and on www.bestbuyrx.com and on www.drugworldcanada.com ) Warning Letter issued to Big Mountain Drugs.

Internet Marketing of Product GermBullet Using False and Misleading Statements on www.germbullet.com and www.nsaroma.com Warning Letter issued to Flu and Cold Defense, LLC.

Feb 11   Departments of Justice and Health and Human Services announce record-breaking recoveries resulting from joint efforts to combat health care fraud.  A new report was released today showing that for every dollar spent on health care-related fraud and abuse investigations in the last three years, the government recovered $7.90.  This is being touted as the highest three-year average return on investment in the 16-year history of the Health Care Fraud and Abuse (HCFAC) Program.  The article made no mention of how many billions of taxpayer money was actually lost due to fraud, only the portion recovered ($14.9 billion).

Feb 8     Security Guard Fires Shots and Wounds 15 Year Old Boy at FDA Office in Bothell, Washington.  The FDA Laboratory, called the Pacific Regional Lab Northwest, analyzes samples of products for safety and compliance with regulations.  The teen is a student at the Secondary Academy for Success, an alternative high school near the FDA building.  The guard who fired the shots is under contract to Federal Protective Service, a division of the Department of Homeland Security that provides security at federal buildings.  The boy was treated at a hospital for a gunshot wound to the foot.  The teen was also involved in a non-injury hit and run accident after fleeing from the lab’s parking lot.  The FPS is working with local law enforcement to investigate the incident.

Feb 8      FDA Approves Pomalyst for Advanced Multiple Myeloma.  The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.     

Feb 7      Guidance for Industry:  Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease.  This guidance explains the FDA’s current thinking about the way researchers can identify and select patients with early Alzheimer’s disease, or those who are at risk of developing the disease, for participation in clinical trials. In recent years, the research community has tried to find ways to identify these patients using criteria that are based on biological indicators (biomarkers). Researchers have also tried to develop sensitive clinical measures that can detect subtle mental decline. You can view and save this guidance at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf

Feb 7      FDA’s Efforts to Address the Misuse and Abuse of Opioids.  The FDA has established a task force to build upon existing initiatives and develop new ones.  You can read more at:  http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm337852.htm?source=govdelivery

 Feb 6      Recalls – Class I

               Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811.  Reason:  Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets. 

Feb 6      Recalls – Class II

Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033.  Reason:  Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.  

               Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.  Reason:  Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness. 

Feb 5      Drugs to be Discontinued

               Doxycycline Hyclate (by Teva), Ephedrine Sulfate (by West-Ward Pharmaceutical), Flecainide Acetate [Tambocor] (by Medics Pharmaceutical Corp), Orphenadrine Citrate [Norflex] (by Medicis Pharmaceutical Corporation), and Rifampin/Isoniazid 300 mg Capsules (by West-Ward Pharmaceutical). 

Feb 4      FDA Approval of Generic Version of Cancer Drug Doxil is Expected to Help Resolve Shortage.  The U.S. Food and Drug Administration today approved the first generic version of the cancer drug Doxil (doxorubicin hydrochloride liposome injection).   Doxorubicin hydrochloride liposome injection is currently on the FDA’s drug shortage list.  For products on the shortage list, the FDA’s Office of Generic Drugs is using a priority review system to expedite the review of generic applications to help alleviate shortages.   The generic is made by Sun Pharma Global FZE (Sun). Doxorubicin hydrochloride liposome injection is administered intravenously by a health care professional. Sun’s generic will be available in 20 milligram and 50 milligram vials.

Feb 3      Manual of Policies and Procedures: Applications for Parenteral Products in Plastic Immediate Containers.   You can download this policy at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM081999.pdf?source=govdelivery  

Feb 1      Draft Guidance for Industry:  S10 Photosafety Evaluation of Pharmaceuticals.  To download go to:

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM337572.pdf?source=govdelivery

Feb 1      Acetaminophen Toxicity White Paper.  Although acetaminophen overdose is very rare in the context of its broad usage, overdose can be toxic and lead to acute liver failure.   Acetaminophen Best Practices Task Group, which produced Version 1.0 of a White Paper and an update, “NCPDP Recommendations for Improved Prescription Container Labels for Medicines Containing Acetaminophen, Version 1.1”.  You can download this document at:  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM266631.pdf?source=govdelivery

Feb 1      Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling.  This guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome, specifically DNA sequence variants, could affect a drug's pharmacokinetics (PK), pharmacodynamics (PD), efficacy, or safety. The guidance provides recommendations on when and how genomic principles should be considered and applied in early-phase clinical studies to address questions arising during drug development and regulatory review.  You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM337169.pdf?source=govdelivery

Jan 31     Guidance for Industry:  Guidance Agenda: New & Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2013.   Download at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf 

Jan 30    Recalls – Class II

               Lisinopril Tablets, USP 40 mg, Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.   Reason: Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.

               Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg.  Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.  Reason:  Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.

               PredniSONE Tablets, USP, 20 mg, Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.  Reason:  Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.   

               Propylthiouracil Tablets, USP, 50 mg, Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.  Reason:  Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets. 

Jan 29   FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder.  The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).  HoFH, an inherited condition that affects about one out of every one million people in the United States, occurs when the body is unable to remove LDL-C, often called “bad” cholesterol, from the blood causing abnormally high levels of circulating LDL-C. For those with HoFH, heart attacks and death often occur before age 30. Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide) to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.

Jan 25     Guidance For Industry:  Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.  This guidance provides, among other things, the requirements for a valid electronic submission under section 745A (a) of the FD&C Act. In accordance with section 745A (a), following the issuance of a final guidance on this topic, submission types identified in this draft guidance must be submitted electronically (except for submissions that are exempted), in a format that FDA can process, review and archive. Currently, the Agency can process, review and archive electronic submissions made using the electronic common technical document (eCTD) specifications. Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review and archive will not be filed, unless exempted from the electronic submission requirement. At the same time, this document also provides guidance on FDA’s interpretation of the statutory electronic submission requirement and the Agency’s current thinking on the best means for implementing other aspects of the electronic submission program.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf?source=govdelivery 

Jan 25    Current Good Manufacturing Practice Requirements for Combination Products.   FDA has issued a regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for “single-entity” and “co-packaged” combination products.   Read the Federal Register Notice at:  http://www.gpo.gov/fdsys/pkg/FR-2013-01-22/pdf/2013-01068.pdf   

Jan 25    Warning Letters

               NX Generation Ltd., Hauppauge, NY 11788 – Issued to Mr. Michael S. Lewis, President 

Current Good Manufacturing Practice (cGMP) violations for dietary supplements

Novo Nordisk A/S, Bagsvaerd, Denmark – Issued to Mr. Lars Rebien Sorensen, President

Current Good Manufacturing Practice (cGMP) violations for sterile products

Jan 23    FDA approves Exjade to remove excess iron in patients with genetic blood disorder.  The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

Jan 17    Generic Drug User Fee Amendments (GDUFA) Facility Fees for 2013.                                              Domestic FDF facility:  $175,389
Foreign FDF facility: $190,389
Domestic API facility:  $26,458
Foreign API facility:  $41,458           

In FY 2013, fees will be due by March 4, 2013.  Fees for FYs 2014 to 2017 will be due the first business day on or after October 1 of each fiscal year.  Any person that owns a facility that is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce one or more generic drug FDFs and/or APIs is required to pay facility fees.   For a more complete explanation, go to:  http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319566.htm?source=govdelivery 

Jan 16    FDA Approves New Seasonal Influenza Vaccine Made Using Novel Technology.  The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. 

Jan 15    FDA/CDER Small Business Chronicles.  The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Breakthrough Therapies. In this issue, we discuss a new program to help expedite the development of new drugs that could potentially offer a substantial improvement over existing therapies for patients with serious or life-threatening diseases who are especially in need of new safe and effective treatments.  You can read/download a copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM335628.pdf?source=govdelivery

Previous newsletters are also archived on the webpage at: http://www.fda.gov/cdersmallbusinesschronicles.  

Jan 11       FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist).  The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Today’s announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist.   FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products

Jan 9      Recalls – Class II

               Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01.  Reason:  Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

               Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; Abbott Laboratories North Chicago, IL 60064 U.S.A.  Reason:  Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets. 

Jan 9      FDA issues draft guidance on abuse-deterrent opioids.  “The FDA is extremely concerned about the inappropriate use of prescription opioids, which is a major public health challenge for our nation,” said FDA Commissioner Margaret A. Hamburg, M.D. “This draft guidance is an important part of a larger effort by FDA aimed at preventing prescription drug abuse and misuse.”   You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 

Jan 7      FDA Issues Two New Guidance Documents.

               Safety Reporting Requirements for INDs and BA/BE Studies.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf?source=govdelivery

               Safety Reporting Requirements for INDs and BA/BE Studies – Small Entity Compliance Guide.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332846.pdf?source=govdelivery 

Jan 4      Guidance for Industry. 

               CDER Guidance New/Revised/Withdrawn in 2102.  You can see the list at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM299352.pdf?source=govdelivery

Dec 21    FDA Expands Tamiflu’s Use to Treat Children Younger than 1 Year.  The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days.  The drug is not approved to prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old.  Tamiflu was approved in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days. It has since been approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than two days, and to prevent flu in adults and children ages 1 year and older.  Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 milligrams per kilogram twice daily for five days. These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu.

Dec 20       Reumofan Plus Relabeled and Sold as WOW.  The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful product Reumofan Plus, marketed as a dietary supplement, is being relabeled and sold under the name “WOW.”  The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.  FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocrabamol (a muscle relaxant).  These ingredients have the potential to cause serious injury. 

               FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus.  The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.          

 Dec 18    Drugs to be Discontinued Ursodiol Tablets, USP, 250 mg.  Teva Pharmaceuticals USA has made a business decision to discontinue all strengths of Ursodiol Tablets.

Dec 17    International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances.  This guidance describes approaches to developing and understanding the manufacturing process of the drug substance, and also provides guidance on what information should be provided in Module 3 of the Common Technical Document (CTD) sections 3.2.S.2.2 – 3.2.S.2.6. It addresses aspects of development and manufacture that pertain to drug substance, including the presence of steps designed to reduce impurities. In addition, this guidance provides further clarification on the principles and concepts described in the ICH guidance, Q8 Pharmaceutical Development (ICH Q8), Q9 Quality Risk Management (ICH Q9), and Q10 Pharmaceutical Quality System (ICH Q10), as they pertain to the development and manufacture of drug substance.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf?source=govdelivery

Dec 17    Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products.  This guidance provides the pharmaceutical industry with CDER’s current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the guidance recommends that you, as part of the pharmaceutical industry, avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription products.   Obtain a copy from:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM294086.pdf 

Dec 17    Draft Guidance for Industry:  Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.  You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf?source=govdelivery

Dec 14    Prescription Drug User Fee Act (PDUFA).   Establishment of PDUFA rates for 2013 was published in August.  Fe, , es are now due.  For more information, go to this Federal Register Notice:  http://www.gpo.gov/fdsys/pkg/FR-2012-08-01/pdf/2012-18711.pdf

Dec 7      Recalls:  Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg.  Mylan announced a voluntary nationwide recall to the retail level of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Lots 3037841, 3040859 and 3042573) due to potential for oversized tablets.  The three lots, manufactured by Qualitest Pharmaceuticals, were repackaged and distributed by Mylan in unit dose (CD100) under the UDL Laboratories label. The lot numbers are Lots 3037841, 3040859 and 3042573.

Dec 4      Two-Week Grace Period Announced for Generic Drug Facility Identification.  The FY 2013 reporting period for facility self-identification closed on December 3, 2012.  Under the statute, generic drug products manufactured in facilities that have not self-identified, or including active ingredients manufactured in facilities that have not self-identified, are misbranded.  FDA is announcing, however, that there will be a two-week grace period, until December 18, 2012, in which facilities that have not yet successfully completed the self-identification process may do so without penalty.   To date, more than 1,700 facilities have self-identified for FY 2013.   This figure is below estimates of the universe of generic drug facilities.   Similarly, an analysis of facilities identified in Abbreviated New Drug Applications and Prior Approval Supplements submitted since October 1, 2012 suggests that not all facilities are self-identifying.  One out of eight facilities in these recent submissions has failed to self-identify, a trend that, if uncorrected, will result in higher individual facility fee amounts.  Answers to specific questions about who must self-identify, what type of information is to be submitted and the means and format for submission of this information is available at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm. 

          Specialty Pharma Newsletter (October-November 2012)

Nov 21   Recalls – Class II 

All sterile and non-sterile products manufactured by Ameridose, LLC Westborough, MA.  All lot codes within expiry date due to lack of assurance of sterility and GMP deficiencies.

 Veniafaxine ER 150 mg, 30 tablets bottle, generic for Effexor, NDC 42549-684-30 packaged and distributed by Stat Rx USA, LLC, Gainesville, GA.  Lot # A00984, Expiry 1/14 - due to Label Mix-up: Product was incorrectly labeled with “Tabs” instead of “Capsules”.

Nov 21   Recalls – Class III

AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 2.5%) and AcneFree Pore Cleanser (benzoyl peroxide 2.5%) manufactured by Valeant Pharmaceuticals and distributed by University Medical Pharmaceuticals Corp., Irvine, CA 92618.  All lots with expiry dates between 10/10/12 and 10/10/14 are recalled due to subpotent benzoyl peroxide. 

Nov 20   CDER Small Business Update – Availability of archived GDUFA-Self ID Webinars. GDUFA requires owners of facilities producing, or intending to produce, human generic drugs, active pharmaceutical ingredients, and certain other sites and organizations that support the manufacture or approval of these products to provide identification information annually to FDA. Self-identification is distinct from the requirement to register and list (under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act), though the process for submitting information is similar. The fiscal year 2013 reporting period opened at the beginning of October and closes on December 3, 2012.   Technical walkthrough webinars, with live question and answer sessions, were held on November 19 from 07:00 – 08:00 am EST and on November 20, 2012 from 11:00 am – 12:00 pm EST. Please watch the webinars by going to: 

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm327565.htm   

Additional information on self-identification is available at:

http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm320942.htm

Previous presentations on self-identification requirements and technical walk-throughs are available at http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm311918.htm  

Nov 14   Guidance for Industry:  Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, and   Anti-asthmatic Drug Products for Over-the-Counter Hu,, man Use. 

This guidance can be downloaded at:  

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm327834.htm?source=govdelivery

Nov 7     Recalls – Class II

Up & Up Brand, Kids foaming hand sanitizer, both Apple-cleani and Sweet Melon manufactured by DermaCare, Inc. and distributed by Target Corp., Minneapolis, MN 55403.  Reason:  Microbial Contamination of Non-Sterile products.  Laboratory findings of high total plate count above specification!

Nov 6     FDA Approves Xeljanz for Rheumatoid Arthritis.  The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.   RA is an autoimmune disease, in which the body's immune system mistakenly attacks healthy tissue leading to inflammation of the joints and surrounding tissues. According to the Centers for Disease Control and Prevention, RA affects an estimated 1.5 million Americans. Xeljanz, a pill taken twice daily, works by blocking molecules called “Janus kinases,” which are important in the joint inflammation of RA.

 Nov 6     Warning Letters

Warning Letter Issued to CocoKefir, LLC. Medina Minnesota 55340.  Inspection revealed serious violations of Title 21, Code of Federal Regulations (21 CFR), Part 111, Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, which resulted in adulterated products.    Specifically, the company has failed to prepare and follow a written master manufacturing record, has failed to establish product specifications for the identity, purity, strength, and composition of each batch, failed to establish component specifications, failed to conduct at least one appropriate test or examination before using a component, failed to establish and follow written procedures for the responsibilities of quality control operations.  This is not an exhaustive list of violations.

Nov 2     Warning Letters  

Warning Letter issued to Atrium, Inc., Wautoma, Wisconsin 54982.  Inspection revealed serious violations of Title 21, Code of Federal Regulations (21 CFR), Part 111, Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements which resulted in adulterated products.  Among the violations were failure to establish component specifications and failure to establish product specifications. 

Nov 2     Recalls – Class II 

Kombiglyze XR (saxagliption and metformin HCl, extended release) manufactured by Bristol-Meyers Squibb Company, Princeton, NJ 08543.  Reason:  Some physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5 mg/1000 mg on the external package carton whereas the contents were Kombiglyze XR 5.0 mg/500 mg blister packaged tablets. 

Doxazosin Tablets, USP, 2mg, 100 count bottles manufactured by Alphapharm PTY, Ltd for Mylan Pharmaceuticals, Morgantown, WV 26505.  Reason:  Cross Contamination with other products.  During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.

CVS Pharmacy Fiber Capsules, Dietary Fiber Supplement 100 capsules per bottle and  WalMart Equate Fiber Therapy, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, and Valu Merchandisers Best Choice Psyllium Fiber Supplement, 100 capsules per bottle, and  Sam’s, (Bentonville, AR) Simply Right Healthcare Fiber Capsules, 400 capsules per bottle, and  Cardinal Health’s Leader Fiber Capsules, 100 capsules per bottle manufactured by Raritan Pharmaceuticals, Inc., East Brunswick, NJ.  Reason: Microbial Contamination of Non-sterile products by C. difficile discovered in raw material.

Zovia, Lutera, Necon, and Zenchent tablets in 28 count dispenser cartons manufactured for Watson Pharma, Inc., by Watson Laboratories, Inc., Corona, CA 92880.  Reason:  Cross Contamination with other products (hydrochlorothiazide).

Nov 1      Drug Shortages Resulting From the Voluntary Shutdown of Ameridose and the Recall of Ameridose Products.  FDA is aware that this may affect supplies of certain life-saving drugs for some health care systems. FDA has identified six Ameridose products on the FDA critical shortage list, which already were in shortage prior to the recall.  The recall has the potential to exacerbate one or more of these shortages: Sodium Bicarbonate Injection, Succinylcholine Injection, Atropine Sulfate Injection, Bupivacaine Hydrochloride Injection, Lidocaine Hydrochloride Injection, and Furosemide Injection.  For these 6 drugs in shortage, these are the actions FDA is working with manufacturers of these 6 drugs requesting that they ramp up production.  If the manufacturers of critical drugs intended for the U.S. are not able to meet U.S. patient needs, FDA will explore companies that are willing and able to import foreign drugs to address the shortage in the U.S.

Nov 1     Drug Information Update - Update on NECC Products: Samples of betamethasone and cardioplegia solution test positive for bacterial contamination. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are reporting laboratory results from samples of two additional recalled NECC products – preservative free betamethasone and cardioplegia solution. Previously, the fungus Exserohilum rostratum was identified in NECC-supplied, preservative-free methylprednisolone acetate (MPA).  The FDA and CDC laboratories have identified bacteria present in three separate lots (batches) of NECC-supplied preservative-free betamethasone, with each lot producing different culture results, and in a single lot of NECC cardioplegia solution.  The clinical significance of these results is not known. Both Bacillus idriensis and Bacillus circulans have been rarely reported as a cause of human disease. CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, CDC has not received reports of laboratory-confirmed cases of infection due to Bacillus or closely related organisms linked to betamethasone or cardioplegia solution from NECC.  Fungal cultures for betamethasone and cardioplegia solution are pending and the presence of additional microbial organisms and/or fungus in these products cannot be ruled out at this time.

Oct 31        Ameridose Issues Recall of All Products.  Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.  During the course of its on-going inspection of their facility, FDA has notified Ameridose that it will be seeking improvements in Ameridose’s sterility testing process.  Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death. Ameridose has not received any adverse reports related to the products subject to this recall and neither Ameridose nor the FDA has identified impurities in any Ameridose products.  Nevertheless, out of an abundance of caution, we are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA’s recommendations.   A full list of products will be available this afternoon at www.ameridose.com.

 Oct 31    The Science of Small Clinical Trials Course: Update.  This course will be recorded and archived for later viewing on the FDA website.  Also, due to demand, live webcast is now open to the general public. In-person registration is full.  Webcast registration is available at: https://events-support.com/events/FDA-NIH_Science_Small_Clinical_Trials?source=govdelivery

Oct 31    The Science of Small Clinical Trials Course.  FDA, together with the NIH Office of Rare Diseases Research, National Center for Advancing Translational Sciences, is announcing a course entitled “The Science of Small Clinical Trials.”  The goal of this course is to engage and educate FDA reviewers, NIH scientists, clinicians, academics and industry representatives with experience in human subject research, seeking to build upon their existing knowledge and to obtain a broader context of what is known about small clinical trials across medical products (e.g. drugs, biologics, and devices).  Date and Time: The course will be held on November 27, 2012, from 8 a.m. to 5 p.m., and November 28, 2012, from 8 a.m. to 3 p.m.  Location: The course will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Section A, Silver Spring, MD 20993-0002.

Oct 26     Drug Information Update - FDA reports conditions observed at New England Compounding Center facility.    Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC). The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass. facility.  The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.  The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations.

Oct 25    Generic Drug User Fee—Abbreviated New Drug Application, Prior Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 2013.  Learn more at:  http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26256.pdf?source=govdelivery

Oct 25    Generic Drug User Fee—Backlog Fee Rate for Fiscal Year 2013.  Read details at:  http://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26257.pdf?source=govdelivery

Oct 25    FDA Drug Safety Communication: Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays.  The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline.  The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as coma, decreased heart rate, decreased breathing, and sedation (sleepiness) have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children. Most of these redness-relief eye drops and nasal decongestant sprays currently do not come packaged with child-resistant closures, so children can accidentally ingest the drug if the bottles are within easy reach.

Oct 24    Recalls – Class III 

Children’s Cetrizine HCl Chewable tablets, 5 mg, 30 count blister pack manufactured in India by Sandoz Private, Ltd., for Sandoz, Inc. , Princeton, NJ.   Reason:  Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester).

Recalls – Class II  

Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement distributed by Earthborn Products, San Diego, CA 92103.  This product is marketed without an approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.

Oct 23    Warning Letters

Warning Letter Issued to International Laboratories (Canada) Ltd. Calgary, Alberta   Recent inspection revealed significant violations of current good manufacturing practice (cGMP) regulation for finished pharmaceuticals causing drug products manufactured by International Laboratories to be adulterated.  Some violations cited are:  1.)  the firm has not established reliability of supplier’s analysis through appropriate validation,  2.)  the firm has not established finished product specifications for each product and does not have identity and assay test procedures for each product,  3.) the master production record does not include an accurate statement of weight for each component, and   4.)  the control records do not contain complete manufacturing and control instructions, sampling and test procedures, special notations or precautions to be followed.

Oct 22   Warning Letters

Warning Letter Issued to Health Breakthroughs International, LLC.   Recent inspection revealed several products promoted for conditions that cause the products to be drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  Examples are:

·         Amazing C
"Vitamin C [an ingredient in your product] ... heal the small intestines."

·         MPS-Gold 100
 “Protection against cold and flu ... "
"The reduction of pain and inflammation, decrease of systemic candida ... "

·         Power Herbal Formula
 "Health Benefits. .. Men ... report resolution of erectile disorders." 

In addition, even if these products were not unapproved new drugs, they would be misbranded as dietary supplements. 

Oct 17    Recalls – Class III

Prometh VC Plain and Prometh VC with Codeine Cough Syrup manufactured by Actavis Mid Atlantic, LLC, Lincolnton, NC 28092.  Reason:  Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

Moexipril HCl Tablets 7.5 mg, 100 tablets, Rx only, manufactured by Paddock Laboratories, Inc. Minneapolis, MN 55427.  Reason:  A non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.

Oct 11    FDA/CDER Small Business Chronicles.  The subject of this month’s issue is “PDUFA”. 

You can download your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM323487.pdf?source=govdelivery

 Oct 10    Recalls – Class II 

Famotidine Tablets, USP, 20 mg 100 count bottles manufactured by Mylan Pharmaceuticals, Inc., Morgantown, WV 26505.  Reason:  Impurities/Degradation Products: Out of specification results for related compounds during routine stability testing.

Oct 10    Recalls – Class III

buPROPion HCl Extended Release tablets, 150 mg and 300 mg, distributed by McKesson Packaging Services, Concord, NC 28027.  Reason:  Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

Oct 9      Warning Letters  

Warning Letter Issued to PSS World Medical, Inc., Jacksonville, FL 32216   Recent inspection of your pharmaceutical repackaging facility, Stat Rx USA, LLC, Gainesville, GA 30501 identified significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals.  Observed specific violations included, but are not limited to, the following: 

1.      Your firm failed to ensure that returned drugs meet appropriate standards of safety, identity, strength, quality and purity prior to redistributing.  21 C.F.R. § 211.204

2.      Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expiration dates.  21 C.F.R. § 211.166(a)   

3.      Your firm has failed to retain an appropriately identified reserve sample that is representative of each lot or batch of drug product. 21 C.F.R. § 211.170(b)

Oct 9      Guidance for Industry - E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs   Questions and Answers (R1). 

You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073161.pdf

Oct 5      Warning Letters 

Warning Letter Issued to Avon Products, Inc., New York, NY 10105.  Recent review of the Avon website at the internet address http://www.avon.com revealed that several products are offered for intended uses that cause these products to be drugs under section 201(g)(1)(c) of the Federal Food, Drug, and Cosmetic Act (the Act).  Marketing of these products with claims evidencing these uses violates the Act.

Oct 5      Guidance for Industry.  Acute Bacterial Sinusitis: Developing Drugs for Treatment. 

You can download a copy at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm322630.htm?source=govdelivery

 Specialty Pharma Newsletter (September 2012)

Oct 5      Guidance For Industry

Complicated Intra-Abdominal Infections: Developing Drugs for Treatment Draft.  You can download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm321390.pdf?source=govdelivery

Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With COPD:  Developing Antimicrobial Drugs for Treatment Draft.   You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070935.pdf?source=govdelivery

Oct 5      FDA takes action against thousands of illegal Internet pharmacies.  The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.  The announcement takes place during the 5th annual International Internet Week of Action (IIWA), a global cooperative effort to combat the online sale and distribution of potentially counterfeit and illegal medical products. This year’s effort – Operation Pangea V – operated between Sept. 25 and Oct. 2 and resulted in the shutdown of more than 18,000 illegal pharmacy websites and the seizure of about $10.5 million worth of pharmaceuticals worldwide.

Oct 4      Guidance For Industry

1.      Acute Bacterial Otitis Media: Developing Drugs for Treatment.  You can download it at:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070947.pdf?source=govdelivery

2.      Initial Completeness Assessments for Type II API DMFs Under GDUFA Draft.  You can find it at:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321884.pdf?source=govdelivery

Oct 4      Manual of Policies and Procedures:  Determination of Major/Minor Amendments to ANDAs. 

This is available at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM322213.pdf?source=govdelivery

Oct 3      Enforcement Reports.  The following products have been marketed without approved ANDA/NDA:

Ten Hard Days Capsule, Man King Capsules, and Japan Weight Loss Blue Capsules all from www.vitaminbestbuy.com    There are Class I recalls underway for all lots.

Oct 3      Warning Letters Issued to:

1.      Julio Bernabe, Managing Member, Andes Natural Skin Care LLC, Carson City, NV 89701

“The claims for Andes products BioSkinCare, Bio Skin Rejuvenation, BioSkinclear, Bio Acne Care, BioSkinforte, BioSkinexfol, and BioSkinrepair on your web sites indi, , cate that these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act. The marketing of these products with claims evidencing these intended uses violates the Act.”

2.      Ian Strassler, President, Janson Beckett, Inc., West Berlin, NJ 08091

“The claims for Janson Beckett products DermaExcel 7; AlphaDerma CE; OkuSil Intensive Eye Rejuvenating Serum with 10% Argireline; 10% Argireline & Trace Mineral Enriched Facial Skin Prep; Vitamin C&C Facial Serum; Alpha Lipoic Acid Vitamin C Ester & DMAE Moisturizing Day Cream; Alpha Lipoic Acid Vitamin C Ester & DMAE Night Cream; and BeautiFull Lips™ Lip Plumper on your web site indicate that these products are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”

3.      eyal@pronet-ltd.com
“The United States Food and Drug Administration (FDA) recently reviewed your websites ([approximately 200] listed in the table located at the bottom of this letter) and has determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), 502(a), 502(f), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(a), 352(f), 353(b), and 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.”

4.      Ms. Jennifer Wang, Quzhou Chemsyn Pharm Co., Ltd, Zhejiang, China 324004

“FDA notified you that records indicated your establishment was not duly registered and informed of the steps you needed to take to become duly registered and to list your products. Our records indicate you have not availed yourself of this opportunity to register. Y ou should take action immediately to register the establishment at Kecheng District Quzhou City, Zhejian Province. Zhejiang, China 324004, and ensure that you have properly listed drugs being offered for import to the United States that are manufactured there.”

Oct  2     Small Biz Buzz is announcing the FDA’s Clinical Investigator Training Course for 2012  It will be held on Dates: November 13-15, 2012 at the Holiday Inn, College Park, MD  20740  Registration link and course details: http://evm.auxserv.duke.edu/iebms/logon/log_p2_addedit.aspx?AppSessionID=ej6fc8fg5ffpfaneioffnfepfbk&sessionid=ej5fc0fg4ffmfamei4ff7fekfc3&eventid=46475&mode=add

Last day to register: November 2.  Course Fee $400.

Oct 2      Small Biz Buzz is announcing that under GDUFA human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA.

Self-identification information must be submitted by November 30, 2012.

In addition, under GDUFA DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application, and Type II API DMFs must undergo an FDA initial completeness assessment.

Refer to Federal Register notice at:  http://www.ofr.gov/OFRUpload/OFRData/2012-24325_PI.pdf?source=govdelivery

Sep 28    Draft Guidance: ANDAs: Stability Testing of Drug Substances and Products

FDA is recommending that generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonization (ICH) guidance Q1A(R2) through Q1E. The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.  You can download the guidance document at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320590.pdf

Sep 28    New FDA Task Force Will Support Innovation in Antibacterial Drug Development

This internal task force will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.  As part of its work, the Antibacterial Drug Development Task Force will assist in developing and revising guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.  Research and development for new antibacterial drugs has been in decline in recent decades, and the number of new FDA-approved antibacterial drugs has been falling steadily since the 1980s. During this time, the persistent and sometimes indiscriminate use of existing antibacterial drugs worldwide has resulted in a decrease in the effectiveness of these drugs. This phenomenon, known as antibacterial drug resistance or antibiotic resistance, has become a serious issue of global concern.  More than 70 percent of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections. In the United States, nearly 2 million Americans developed HAIs in 2002, resulting in about 99,000 deaths.  For more information go to:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm320643.htm

Sep 26    Manual of Policies and Procedures:  Guidance on Packaging of Test Batches for ANDA Submissions.

This can be downloaded at:   http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM079782.pdf?source=govdelivery

Sep 24    Med Watch Safety Alert.  Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets.  Affected lots:   519406A and 521759A, both with the expiry date April 2014.  Consumption may result in an adverse event, including liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day..  

Sep 18   The Office of Generic Drugs Has Recently Posted a Pharmaceutical Development Report Entitled “Quality By Design for ANDAs:  An Example for Modified Release Dosage Forms.   You can download it at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM286595.pdf 

They have also published, “Quality By Design for ANDAs: An Example for Immediate Release Dosage Forms.  It can be downloaded at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM304305.pdf  

Sep 18    FDA/CDER Small Business Chronicles September 18 issue discusses New Drug Quality.  You can read it at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM319879.pdf?source=govdelivery  

Sep 14    The 2nd annual U.S. Conference on Rare Diseases and Orphan Products will take place October 22-24 in Washington DC. Everyone is welcome.  Learn more at:  http://www.diahome.org/en/Flagship-Meetings/12017-Rare-Diseases.aspx

Sep 12   Drug Information Update - FDA approves production of imaging agent that helps detect prostate cancer.  The U.S. Food and Drug Administration today approved the production and use of Choline C 11 Injection, a Positron Emission Tomography (PET) imaging agent used to help detect recurrent prostate cancer.  Choline C 11 Injection is administered intravenously to produce an image that helps to locate specific body sites for follow-up tissue sampling and testing in men with recurrent prostate cancer.  PET imaging with Choline C 11 Injection is performed in patients whose blood prostate specific antigen (PSA) levels are increasing after earlier treatment for prostate cancer. An elevated PSA result suggests that prostate cancer may have returned, even though conventional imaging tests, such as computerized tomography (CT), have not shown any signs of cancer. PET imaging is not a replacement for tissue sampling and testing.  The Mayo Clinic is now the first FDA-approved facility to produce Choline C 11 Injection.

Sep  4     Sun Pharmaceutical Industries, Inc. Issues Nationwide Voluntary Recall of One Lot of Nimodipine Capsules (30 mg) marketed by Caraco Pharmaceutical Laboratories, Ltd., due to Crystallization of the Fill Material.  Sun Inc. commenced the recall as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution of this lot as identified by a customer complaint. No adverse events have been reported at this time.

Sep 4      FDA approves new treatment for a type of late stage prostate cancer.  The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.  Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012.  Read more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317838.htm?source=govdelivery

Aug 23   Guidance For Industry

1.      Generic Drug User Fee Amendments of 2012: Questions and Answers.  

You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf?source=govdelivery 

2.      Self-Identification of Generic Drug Facilities, Sites, and Organizations.

As required by GDUFA, FDA will issue a self-identification requirement notice in the Federal

Register in the coming weeks explaining that human generic drug facilities, sites, and

organizations are required to submit identification information electronically to FDA within 60

days. The notice will also list the self-identification information that must be submitted. 

You can download this guidance at: 

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316672.pdf?source=govdelivery

Aug 17   Prescription Drug User Fees for 2013

                               Fee category                              Fee rates for FY 2013

               Applications:

                   Requiring clinical data                                          $1,958,800

                   Not requiring clinical data                                         979,400

                   Supplements requiring clinical data                         979,400

               Establishments                                                                526,500

               Products                                                                             98,380

               You can find more detail in the Federal Register at:

               http://www.gpo.gov/fdsys/pkg/FR-2012-08-01/pdf/2012-18711.pdf

Aug 17   Guidance For Industry:  User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.  You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079298.pdf  

Aug 15   Drug Information Update - FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death.  Recently, three pediatric deaths and one non-fatal but life-threatening case of respiratory depression were documented in the medical literature. These children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range. When codeine is ingested, it is converted to morphine in the liver by an enzyme called cytochrome P450 2D6 (CYP2D6). Some people have DNA variations that make this enzyme more active, causing codeine to be converted to morphine faster and more completely than in other people. These “ultra-rapid metabolizers” are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal. Taking codeine after tonsillectomy and/or adenoidectomy may increase the risk for breathing problems and death in children who are “ultra-rapid metabolizers.” The estimated number of “ultra-rapid metabolizers” is generally 1 to 7 per 100 people, but may be as high as 28 per 100 people in some ethnic groups.

Aug 13   2011 Obesity Rates Now Available   The 2011 CDC map detailing adult obesity prevalence for all U.S. states based on Behavioral Risk Factor Surveillance System (BRFSS) data is now available. In 2011, rates of adult obesity remain high, with state estimates ranging from 20.7 percent in Colorado to 34.9 percent in Mississippi. No state had a prevalence of adult obesity less than 20 percent, and 12 states (Alabama, Arkansas, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Oklahoma, South Carolina, Texas, and West Virginia) had a prevalence of 30 percent or more. The South had the highest prevalence of adult obesity (29.5 percent), followed by the Midwest (29 percent), the Northeast (25.3 percent) and the West (24.3 percent).

Aug 9     New and Revised Draft Guidances CDER is Planning to Publish in Calendar Year 2012.  You can review this agenda at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm314767.htm?source=govdelivery

Aug 7     FDA/CDER Small Business Chronicles September 18 issue discusses The Unapproved Universe.  You can read it at: 

    http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM314558.pdf?source=govdelivery  

Aug 6  FDA Notification to Industry: Products using oils, glycerin, or proteins that were derived from the Jatropha plant may have toxic effects.   FDA is notifying the regulated community that oils, glycerin, and proteins commonly used in the production of human and animal food, medical products, cosmetics, and other FDA-regulated products may contain toxins if they are derived from the Jatropha plant.                   

At this time, the FDA is unaware of any intentional substitution or contamination in FDA-regulated finished products or components derived from the Jatropha plant. However, given the significant overlap among the supply chains of FDA-regulated products, the FDA is advising industry to be aware of the potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant. 

Jul 25     Guidance For Industry:  Points to Consider for Q8, Q9, and Q10

           ,     The ICH Quality Implementation Working Group (Q-IWG) has prepared these Points to Consider

document covering topics relevant to the implementation of ICH Q8(R2), Q9, and Q10, which

supplement the existing guidance Q8, Q9, and Q10 Questions & Answers 3 and workshop training materials 4 already produced by this group. You can download th, is guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM313094.pdf

 Jul 24 New CDC Vital Signs Report: Methadone contribute​d to 1 in 3 prescription painkiller deaths in 2009. Prescription painkiller overdoses were responsible for more than 15,500 deaths in 2009. While all prescription painkillers have contributed to an increase in overdose deaths over the last decade, methadone has played a central role in the epidemic. About 5,000 people die every year of overdoses related to methadone. Six times as many people died of methadone overdoses in 2009 , than a decade before. Methadone has been used safely and effectively to treat addiction to heroine and prescription painkillers, but healthcare providers should prescribe methadone for pain only when other painkillers have not been effective. To learn more about the risks associated with methadone as a pain killer please see: http://www.cdc.gov/vitalsigns/MethadoneOverdoses/index.html

Jul 24 FDA prompts companies to remove certain unapproved oxycodone products from market.

FDA today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA's Unapproved Drugs Initiative to remove unapproved new drugs from the market.

The FDA action affects companies that manufacture and distribute unapproved single-ingredient, immediate-release oxycodone drug products in oral dosage forms, including tablets, capsules and oral solutions. These products have not been evaluated by the FDA for safety, effectiveness, manufacturing quality, or appropriate labeling, including dosing information and warnings, and cannot be legally marketed in the United States.

Oxycodone is an opioid analgesic, a class of powerful pain medications. Oxycodone is listed under Schedule II of the Controlled Substances Act with an abuse liability similar to other opioid agonists. Improper labeling and use of oxycodone can lead to overdose and death. FDA recognizes that opioid medications are associated with prescription drug misuse, abuse, and addiction, which have resulted in an increase in injuries and deaths across the United States over the last 10 years.

The FDA's Unapproved Drugs Initiative, which began in June 2006, is the agency's risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process. One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.

Companies with certain products that are subject to this action are expected to stop manufacturing the products within 45 days and stop shipping the products within 90 days. Products that are subject to these timeframes are products that:

- were introduced onto the market before Sept. 19, 2011,

- were listed in the FDA's Drug Registration and Listing System before July 6, 2012, and

- were being commercially used or sold before July 6, 2012.

Companies that continue to market products that fall within this scope of this Federal Register notice are subject to enforcement action including seizure, injunction, or other judicial or administrative proceeding.

Jul 24 Assessment Program for the Enhanced Review Transparency and Communication for NME

NDAs and Original BLAs in PDUFA V –       Request for Comments. FDA is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (the Program).

The Program is part of the FDA performance commitments under the proposed fifth authorization of the Prescription Drug User Fee Act (PDUFA), which, if enacted into law, will allow FDA to collect user fees for the review of human drug and biologics applications for fiscal years (FYs) 2013-2017. The Program is described in detail in section IIB of the document entitled ''PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017.'' The Program will be evaluated by an independent contractor in an interim and final assessment. As part of the FDA performance commitment, FDA is providing a period of 30 days for public comment on the statement of work before letting the contract for the assessment.

Jul 24 Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids

FDA today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications.

ER/LA opioids are highly potent drugs that are approved to treat moderate to severe persistent pain for serious and chronic conditions. The misuse and abuse of these drugs have resulted in a serious public health crisis of addiction, overuse, and death.

The REMS is part of a multi-agency Federal effort to address the growing problem of prescription drug abuse and misuse. The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain. More information at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm

Jul 24 Drug Information Update -      FDA approves Tudorza Pressair to treat chronic obstructive pulmonary disease. The U.S. Food and Drug Administration today approved Tudorza Pressair (aclidinium bromide) for the long-term maintenance treatment of bronchospasm (narrowing of the airways in the lung) associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

COPD is a serious lung disease that makes breathing difficult. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute. COPD is the fourth leading cause of death in the United States. Symptoms can include chest tightness, chronic cough, and excessive phlegm.

Tudorza Pressair, a dry powder inhaler used twice daily, is a long-acting antimuscarinic agent that helps muscles around the large airways of the lungs stay relaxed to improve airflow.

Jul 24 Drug Informatio​n Update -       FDA Drug Safety Communicat​ion: Seizure risk for multiple sclerosis patients who take Ampyra (dalfampri​dine). The U.S. Food and Drug Administration (FDA) is updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine). Using information received from post-market adverse event reports, FDA recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine). The majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.

In addition, FDA is updating the Ampyra drug label to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues. Additionally, patients who miss a dose should not take extra doses—an extra dose of Ampyra can increase seizure risk.

Jul 24 The topic of this month's issue of the FDA/CDER Small Business Chronicles is Orphan Drugs. You can download this 2 page issue at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM311928.pdf?source=govdelivery

Jul 24 Drug Informatio​n Update -       FDA approves Afinitor for advanced breast cancer. The U.S. Food and Drug Administration today approved Afinitor (everolimus) for use in combination with Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.

The drug combination is intended for use in women with recurrence or progression of their cancer after treatment with Femara (letrozole) or Arimidex (anastrozole).

Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease.

Jul 18 Enforcement Report - Recalls

Product: Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only,

Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18

Class II

Reason: Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.

Product: Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming,

Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.

Class II

Reason: Impurities/Degradation Products: exceeded specification at 3 month stability testing

Jul 28 Warning Letter Issued to Prismic Light International, Murfreesboro, TN 37129.      The inspection on January 18-19 revealed Prismic failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(g)(1)] because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for die, tary supplemen, ts. Specifically no system of production and process controls, unlabeled containers, no specifications, no identity testing, failure to establish and follow written procedures for QC, failure to follow a batch record, failure to collect and hold reserve samples, and more.

Jul 20 Enforcement Report – Recalls

Product: Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only.

Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.

Class II Reason: Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets

Product: Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15

Class II Reason: Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.

Jul 17 FDA Approves First Drug for Reducing Risk of Sexually Acquired HIV Infection.     Today, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk. The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older. As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.

Jul 11 Enforcement Report – Recalls Product: Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only. Manufactured in India by: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India. Manufactured for TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-1 Class II Reason: Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight).

Product: Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle. Distributed by: Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08 Class III Reason: Subpotent (single Ingredient Drug): out of specification result for coal tar content assay.

Product: Loxapine Capsules USP, 5mg, 10 mg, 25 mg and 50 mg; 100 count bottle, Rx only. Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0369-01, #0591-0370-01, # 0591-0371-01, #0591-0372-01 Class III Reason: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

July 5 Enforcement Report – Recalls

Product: Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only.

Manufactured by: Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78

Class II

Reason: Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight

Product: Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only.

Manufactured by: TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs.

Class II

Reason: Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Product: Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01.

Manufactured for: Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601

Class II

Reason: Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval

Product: Thyro-Tab 0.050mg., packaged in bulk drums for repackaging.

Manufactured by: The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

Class II

Reason: Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.

Product: Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only.

Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01

Class II

Reason: Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point.

Product: Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle,

Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03

Class II

Reason: Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life.

Jul 3 CDER Small Business Update: Draft Guidance for Over-the-Counter Products that Contain Acetaminop​hen.

FDA today issued draft guidance to manufacturers of over-the-counter (OTC) acetaminophen products, providing alternative language to the liver warning section of the product's labeling. In certain instances, FDA now will allow manufacturers to state the maximum daily dosage as 4,000 mg in a 24-hour period for the liver warning. This language can be used instead of specifying the maximum number of tablets or dosage units for the product, as has been required.

Please find additional information at: http://www.fda.gov/Drugs/DrugSafety/ucm310469.htm

Draft Guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310477.pdf

Jul 2 Guidance for Industry: Comprehensive List of Guidance Documents Published. You can download the list at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery

List of New/Revised/Withdrawn CDER Guidances can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM299352.pdf?source=govdelivery

Jun 27 Enforcement Report – Recall

Product: Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health. Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

Class III Reason: Contraceptive Tablets are Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

Jun 14 Small Business Chronicles: Go Green –File Electronically. You can download this document at:

http://content.govdelivery.com/attachments/USFDA/2012/06/14/file_attachments/134467/2012-06-14-CDERSmallBusinessChronicles.pdf

Jun 13 Enforcement Report – Recalls

Product: Atenolol Tablets USP, 25 mg, a) 100 count bottle (NDC 0093-0787-01), b) 1000 count bottle (NDC 0093-0787-10), Rx only. Recall # D-1362-2012

Recalling Firm: Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,. Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm Initiated recall is on going.

Reason: Presence of Foreign Substance(s): This recall is being carried out due to the potential presence of stainless steel particulates in the tablets

Product: Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in a 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, NDC 0781-5584-36. Recall # D-1368-2012

Recalling Firm: Recalling Firm: Sandoz, Inc., Broomfield, CO, by press release on June 5, 2012 and by letter on June 8, 2012.

Manufacturer: Laboratorios Leon Farma SA, Leon, Spain. Firm initiated recall is ongoing.

Reason: Contraceptive Tablets Out of Sequence: Patient complaint that inactive tablets were found in row 9 of a blister card instead of the appropriate row 13.

Jun 13      Warning Letter Issued to Compania Interacional de Comercio, SA de CV, Del Iziapalapa, Mexico DF, Mexico 09860. The inspection on August 22-25, 2011 identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations caused their drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. Specifically, there are poor CGMP documentation practices in place at their facility, specifically in the area of the disposition and handling of critical analytical data.

Jun 7      Guidance for Industry.  S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals intended for Human Use.  This document can be downloaded from:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074931.pdf?source=govdelivery

Jun 6     U.S. Marshals Seized Misbranded Drugs in Maine  At the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.

According to the complaint, the company has made claims on its website, in promotional materials, and on the products’ labels that its products can diagnose, cure, mitigate, treat or prevent human diseases. The company’s products, including Glucanol, Healthy Trac, Immunol, and Lactopril, meet the FDA definition of drugs because Global Biotechnologies promoted them to treat diseases. However, the company failed to provide adequate directions for use for its drug products, causing those products to be misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.

Earlier, the FDA sent a warning letter to Global Biotechnologies advising the company that making treatment claims on its labels, promotional materials and websites caused the products to be unapproved new drugs and misbranded drugs in violation of the Federal, Food, Drug and Cosmetic Act. At that time, the company committed to removing drug claims cited in the warning letter from its labeling. However, during a recent inspection, the FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs.

Jun 6      Warning Letters.  The Following Companies Have Been Issued Warning Letters for Failure to Register and List.

               C.I. Farmacapsulas SA, Peking Medicine Manufactory, Chinese Peptide Company, Korea Pharma Company, Ltd., Orlane SA, Pan Drugs Limited, and Zhejiang Xianju Chemical Pharmaceutical Factory.

Jun 6      Warning Letter Issued to NorthWestPharmacy.com (a.k.a. Pharmawest Pharmacy, Ltd) for Marketing an Unapproved and Misbranded Drug.  Alitretinoin, trade name, Toctino, is offered for sale on your website "to treat severe long-term eczema that affects the hands ... for patients who have not found success using other corticosteroid treatments."  Although Toctino is approved in Canada, no approved application pursuant to section 505 of the FD&C Act [21 U.S.C. §355] is in effect for this product.

Jun 6      Recalls: Drugs - Class III

PRODUCT

1) Methylin Chewable Tablets (methylphenidate HCl) 2.5 mg, 100 count bottle, Rx only, NDC 59630-760-10. Recall # D-1358-2012; Lot # AMT21102A;

2) Methylin Chewable Tablets (methylphenidate HCl) 5 mg, 100 count bottle, Rx only NDC 59630-761-10. Recall # D-1359-2012; ) Lot # AMT51101A; AMT51102A;

3) Methylin Chewable Tablets (methylphenidate HCl) 10 mg, 100 count bottle, Rx only, NDC 59630-762-10. Recall # D-1360-2012; Lot # AMTIOIlOlA; AMTIOII02A

RECALLING FIRM/MANUFACTURER

Mallinckrodt Inc., Hobart, NY, by letters on March 15, 2012. Firm initiated recall is ongoing.

REASON

Stability Data does not Support Expiration Date: Covidien Mallinckrodt Inc. is conducting a voluntary recall of Methylin Chewable Tablets because of failed stability testing. 

PRODUCT

1) Ropinirole Hydrochloride Tablets, 3 mg, 500 tablets per Bottle, Rx only, NDC 60429-797-05. Recall D-1363-2012; Lot # 102797A, Exp. 11/11; 103538A, 103538B, 103538C, Exp 01/12;

2) Ropinirole Hydrochloride Tablets, 4 mg, 500 tablets per Bottle, Rx only, NDC 60429-798-05. Recall # D-1364-2012; Lot # 103255A, 103255B, Exp.12/11;

3) Ropinirole Hydrochloride Tablets, 5 mg, 500 tablets per Bottle, Rx only, NDC 60429-799-05. Recall # D-1365-2012; Lot # 102799A, 102799B, 102799C, 102799D, Exp 11/11

RECALLING FIRM/MANUFACTURER

Recalling Firm: Golden State Medical Supply Inc., Camarillo, CA, by letter on April 28, 2011. 

Manufacturer: Corepharma LLC, Middlesex, NJ. Firm initiated recall is ongoing.

REASON                                                                                                                                                

Labeling: Incorrect or Missing Package Insert. Recall due to discrepancy with package outsert.

May 31 Benzocaine and Babies: Not a Good Mix.  Parents should not use benzocaine gels or liquids to relieve teething pain for children under 2, who are at particular risk for the rare but serious disease of methemoglobinemia. Adults with heart disease or breathing problems and smokers are also at greater risk for the disease.  Learn more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm306062.htm?source=govdelivery

May 30  Guidance for Industry: Irritable Bowel Syndrome — Clinical Evaluation of Drugs for Treatment.  It can be found and downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM205269.pdf?source=govdelivery

May 30   Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter and Attachments for 2013 has been sent.  You can find the letter at:  http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm149212.htm?source=govdelivery

 May 30  Drugs to be Discontinued: 

               Cognex (tacrine hydrochloride) Capsules 10 mg, 20 mg.  Shionogi has made a business decision to discontinue Cognex® (tacrine hydrochloride), 10 and 20 mg capsules.  There is no remaining inventory within Shionogi, Inc. distribution network.

               Cyanide Antidote Kit.  Akorn is discontinuing the manufacture of this product and the components for use in this product.

 May 30  Recalls: Drugs – Class I

PRODUCT

Kold Sore Spray with liquid sea mineral, 1 fl oz bottle. Recall # D-1355-2012;  All lots.

RECALLING FIRM/MANUFACTURER

Wholistic Herbs, Inc., Dallas, TX, by press release on February 9, 2012 and by letters on February 9, 2012 and March 8, 2012. Firm Initiated recall is ongoing.

REASON

Non-Sterility: This product is intended for use in the eye and was manufactured under non sterile conditions.   

May 30  Recalls: Drugs - Class II

PRODUCT 

Koff & Kold Spray (huang liam, lugol iodine, quercetin), 1 fl oz bottles. Recall # D-1356-2012; all lots

RECALLING FIRM/MANUFACTURER

Wholistic Herbs, Inc., Dallas, TX, by press release on February 9, 2012 and by letters on February 9, 2012 and March 8, 2012. Firm Initiated recall is ongoing.

REASON

CGMP Deviations: This product was manufactured in a manner that lacks good manufacturing practices.

May 30  FDA Warns Consumers About Counterfeit Version of Teva’s Adderall.  The U.S. Food and Drug Administration is warning consumers and health care professionals about a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets that is being purchased on the Internet. Adderall, which is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, is a prescription drug classified as a controlled substance – a class of drugs for which special controls are required for dispensing by pharmacists.

FDA’s preliminary laboratory tests revealed that the counterfeit version of Teva’s Adderall 30 mg tablets contained the wrong active ingredients. Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

May 24  CDER is Soliciting Proposals on a Competitive Basis for Innovative Projects That Will Foster Better Understanding of the Work of CDER and the Impact of That Work on Public Health.  One grant in the amount of $200,000 will be funded.  Find out more information at:  http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-12-023.html?source=govdelivery

May 24  Urgent:  Compounded Prescription Recall.  This is to inform you of a product recall involving: All Sterile Human and Veterinary Prescriptions Distributed by Franck’s Pharmacy.  From November 21, 2011 to May 21, 2012. This recall is being initiated after the U.S. Food and Drug Administration ("FDA") notified us that environmental sampling of our clean room revealed the presence of microorganisms and fungal growth.  No information was available on the FDA Website on the location of “Franck’s Pharmacy”.

 May 24  FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2012.

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our intended audience is the small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.  It will be held June 19-20 at the Westin O’Hare, 6100 North River Road, Rosemont, IL 60018 (847) 698-6000 Registration for the Conference is free.  More at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm304356.htm?source=govdelivery 

May 22  U.S. Marshals Seize Unapproved New Drug From Crescendo Therapeutics LLC.  U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percent in silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, LLC, of Vista, Calif.  The seizure, which took place under a warrant issued by the U.S. District Court for the Southern District of California, follows two FDA inspections of Crescendo.  During the first inspection in April 2011, the FDA found that Crescendo was marketing HybriSil as a prescription topical corticosteroid, intended to treat scars and skin disorders. FDA warned the company in November 2011 that HybriSil was an unapproved new drug product, which could not be marketed without approval by the FDA based on data showing that the product is safe and effective for its intended use. On January 3, 2012, Crescendo submitted an Investigational New Drug Application for HybriSil that permitted the limited distribution of the product for investigational use only. However, a subsequent FDA inspection conducted later that month confirmed that Crescendo continues to distribute HybriSil for non-investigational purposes.  “This action was taken because Crescendo Therapeutics continued to sell unapproved new products.”

May 17  Guidance for Industry: S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.   Download the original guidance at:  http://www.fda, .gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM074957.pdf

Download its addendum (R1) at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf  

May 17  Small Business Chronicles April 12 Issue (updated May 2012).  FDA/CDER Small Business Chronicles, the monthly newsletter of the CDER Small Business Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation.  This two page document is available at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM300173.pdf

May 16  Recalls: Drugs – Class II

PRODUCT

1) Topiramate Tablets, 100 mg, a) 60-count tablets per bottle (NDC 0093-7219-06, UPC 3 0093-7219-06 4), b) 1000-count tablets per bottle (NDC 0093-7219-10, UPC 3 0093-7219-10 1), Rx only. Recall # D-1339-2012; numerous lots

2) Topiramate Tablets, 50 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7540-10, UPC 3 0093-7540-10 6. Recall # D-1340-2013; Lot #: 16T023, 16T024, and 16T026, Exp 03/12;

3) Topiramate Tablets, 200 mg, 1000-count tablets per bottle, Rx only, NDC 0093-7220-10, UPC 3 0093-7220-10 7. Recall # D-1341-2012; Lot #: 30T044, Exp 06/12; and 30T085, Exp 07/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 28, 2012.

Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: The specified lots may not meet the impurity specification through expiry. 

May 16  Recalls: Drugs – Class III

PRODUCT

Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles. Recall # D-1337-2012.  Numerous lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pfizer Inc., New York, NY, by letter on March 16, 2012. 

Manufacturer: Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina. Firm initiated recall is ongoing.

REASON

CGMP deviation; enzymatic hydrolysis time for the gelatin manufacturing process of these lots was increased which may have caused a stronger odor of the product.

May 17  Drug Information Update - FDA Statement Regarding Azithromyc​in (Zithromax) and the Risk of Cardiovascular death.  The U.S. Food and Drug Administration (FDA) is aware of the study published in the New England Journal of Medicine, on May 17, 2012, that compared the risks of cardiovascular death in patients treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), and no antibacterial drug.  The study reported a small increase in cardiovascular deaths and in the risk of death from any cause in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.  FDA is reviewing the results from this study and will communicate any new information that results from the FDA review.

May 9    Recalls and Field Corrections: Drugs – Class II

PRODUCT

Campral (acamprosate calcium) Delayed-Release Tablets, 333 mg, packaged in a) 30-day supply (3 blister cards x 60 tablets) 180 tablets per carton, NDC 0456-3330-60, UPC 3 0456-3330-60 5; b) 10 x 10 blister cards (100 tablets) per carton hospital unit dose, NDC 0456-3330-63, UPC 0 04563 33063 5; and c) 7-day supply (1 blister card x 42 tablets) per Patient Starter Kit, professional sample blister pack, NDC 0456-3330-42; Rx only. Recall # D-1332-2012; numerous lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by letters dated March 19, 2012.

Manufacturers: Merck Sante, Semoy, France;

Forest Pharmaceuticals Inc., Cincinnati OH.

Firm initiated recall is ongoing.

REASON                                                                                                                                                 

Failed USP Dissolution Test Requirements: Failing high results for the acid-stage dissolution test was obtained at the 18-month test interval.

PRODUCT

1) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Cherry Flavor 160 mg per 5 mL pain reliever/fever reducer a) 1 fl oz,. 30 mL UPC 011673574095, b) 2 fl oz, 60ml, UPC 011673574781, c) Twin Pack - 2 fl oz (60ml), UPC 011673574033, d) Twin Pack Promotion - 2 fl oz UPC 011673257424. Recall # D-1335-2012; numerous lots

2) Up and Up Dye Free Infants Acetaminophen Suspension Liquid Grape Flavor 160 mg per 5 mL pain reliever/fever reducer 2 fl oz. 60 mL UPC 011673602781. Recall # D-1336-2012 Lot: 602-3716 12/2013

RECALLING FIRM/MANUFACTURER

Guardian Drug Co. Inc., Dayton, NJ, by letter on April 16, 2012 and issued a web site notification on April 24, 2012. Firm initiated recall is ongoing.

REASON

Mislabeling: Infant acetaminophen suspension product labeling was missing the statement "Under 2 years ask doctor" and the weight-based dosing of the label provides for doses that are higher than what has been recommended for children 2 years and older.

May 9    Recalls: Drugs - Class III

PRODUCT

Lorazepam Oral Concentrate, USP, 2 mg/mL, Rx Only, 30 mL bottle, NDC 0574-0163-30. Recall # D-1333-2012; Lot #s: 2010302121, Exp 07/2012; 2010392922, Exp 09/2012; 2010514031, Exp 12/2012; 2011084759, Exp 02/2013; 2011145313, Exp 04/2013; 2011235889, Exp 06/2013

RECALLING FIRM/MANUFACTURER

Paddock Laboratories, Inc., Minneapolis, MN, by letter dated April 4, 2012. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: This recall has been initiated due to non-conformance to the specification for a specified impurity (Related Compound C) at the 12-month stability test station

PRODUCT

Losartan Potassium Tablets USP, 50 mg, 1000 film coated tablets, NDC 16714-582-03. Recall # D-1334-2012; Lot #G00921A EXP AUG 2013 Lot #G00922A EXP AUG 2013 Lot #G00923A EXP AUG 2013

RECALLING FIRM/MANUFACTURER

Actavis Pharma Manufacturing Private Limited, Kanchipuram, India, by letters dated January 5, 2012. Firm initiated recall is ongoing.

REASON

Presence of Foreign Substance; magnesium stearate excipient used in the product was found to be contaminated with zeolite, calcium hydroxide, dibenzoylmethane and Bisphenol A (BPA).

May 7    Drug Information Update.  Increased Risk of New Types of Cancer in Patients Who Received Revlimid.  The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma.

May 3    Six Month Check-Up:  FDA’s Work on Drug Shortages.  Commissioner Margaret Hamburg has published a document on FDA Voice wherein she explains that since reaching out to industry there has been a six fold increase in early notifications of drug shortages by manufacturers.  You can read her remarks at:  http://blogs.fda.gov/fdavoice/index.php/2012/05/six-month-check-up-fdas-work-on-drug-shortages/?source=govdelivery

Apr 27   FDA Approves Stendra (Avanafil) for Erectile Dysfunction.   Stendra belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. As with other PDE5 inhibitors, Stendra should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure.  Patients who experience a sudden loss of vision or hearing should stop taking PDE5 inhibitors, including Stendra, and call a doctor right away.  The most common side effects reported in greater than 2 percent of patients in the clinical studies of Stendra include headache, redness of the face and other areas (flushing), nasal congestion, common cold-like symptoms (nasopharyngitis), and back pain. In rare cases, patients taking Stendra and other PDE5 inhibitors may get an erection lasting four hours or longer that will not go away (priapism). If this happens, patients should seek immediate medical care.  Results showed that the side effects commonly reported in patients using Stendra did not worsen over time.  Stendra’s safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients were randomly assigned to take Stendra for up to 12 weeks at doses of 50 milligrams (mg), 100 mg or 200 mg, or a placebo as needed about 30 minutes before sexual activity.

Apr 27   Manual of Policies and Procedures.  Requests for Expedited Review of Supplements to Approved ANDAs.  The FDA’s latest thinking on this subject can be reviewed at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM079784.pdf?source=govdelivery

Apr 25   Recalls Pending Classification: Drugs

PRODUCT

DermaZinc Spray, (zinc pyritione) 0.25%, 4 fl.oz. (120 ml), OTC; Lot Number 022110-01, Exp. 02/14.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Quadrant Chemical Corporation, Garland, TX

Manufacturer: Quadrant Chemical Corporation, Garland, TX

REASON FOR RECALL

Subpotent (Single Ingredient) Drug: zinc pyrithione

PRODUCT

Mefloquine HCl Tablets, 250mg, 25 Unit Dose Tablets (5x5), Rx only, NDC 0555-0171-78;

Lot # 34000741A; Expiration date: 7/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA

Manufacturer: Barr Laboratories, Inc. (division of Teva), Forest, VA

REASON FOR RECALL

Low Tablet Weight: Product has the potential of being underweight.

PRODUCT

X-ROCK, All Natural for Men, Dietary Supplement, proprietary blend 432mg, 1 capsule blister pack;

All Lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: XR Industries LLC, Pompano Beach, FL

Manufacturer: CRM Laboratories, Marathon, FL

REASON FOR RECALL

Marketed without an approved NDA/ANDA: Product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).

PRODUCT

Losartan Potassium Tablets USP, 50 mg, 1000 count bottles, NDC 16714-582-03; Lot Numbers

G00921A, G00922A & G00923A, Exp Aug 2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Actavis Totowa LLC, Totowa, NJ

Manufacturer: Actavis Pharma Manufacturing Pvt., Ltd., Tamilnadu, India

REASON FOR RECALL

Presence of Foreign Substance; product may contain magnesium stearate

Apr 25   Recalls And Field Corrections: Drugs – Class II

PRODUCT

1) RegenArouse TM, Natural Female Intimacy Enhancement, 1 Capsule, Herbal Supplement. UPC 816860010079. Recall # D-1318-2012; ) Lot 130100, Exp.12/13;

2) RegenErect TM, Natural Male Enhancement, 1 capsule, Herbal Supplement. UPC 816860010055. Recall # D-1319-2012; Lots 120126, 120127, 120128, and 120129, Exp. 12/13

RECALLING FIRM/MANUFACTURER

Regeneca, Inc, Irvine, CA, by press release on February 10, 2012, and on February 24, 2012. Firm initiated recall is ongoing.

REASON

Marketed Without An Approved NDA/ANDA: FDA lab results found undeclared tadalafil in the product which is used as a treatment for male erectile dysfunction.

PRODUCT

1) Pedia Care Infants Drops for Infants (Acetaminophen) 80mg, 0.5 Fl oz (15mL) UPC Code: 814832011055 and 1.0 Fl oz (30mL) UPC Code: 814832011055 bottles, Fever Reducer, Pain Reliever, Cherry Flavor. Recall # D-1322-2012; Lots Too Numerous To Mention

2) Pedia Care Infants Drops for Infants (Acetaminophen) 80mg, 0.5 Fl oz (15mL) UPC Code: 814832011048 and 1.0 Fl oz (30mL) UPC Code: 814832010966 bottles, Fever Reducer, Pain Reliever, Grape Flavor. Recall # D-1323-2012; Lots Too Numerous To Mention

3) Pedia Care Infants Drops for Infants (Acetaminophen) 80mg, 1.0 Fl oz (30mL) bottles, Fever Reducer, Pain Reliever, Dye Free Cherry Flavor, UPC Code: 814832010942. Recall # D-1324-2012

Lots Too Numerous To Mention

RECALLING FIRM/MANUFACTURER

Recalling Firm: Medtech Products, Inc., Irvington, NY, by letters on March 13, 2012.

Manufacturer: Guardian Drug Co., Dayton, NJ. Firm initiated recall is ongoing.

REASON

Resuspension problems; acetaminophen may come out of suspension in the product.

PRODUCT

Alka-Seltzer Plus(R) Severe Sinus, Congestion Allergy & Cough Formula, Acetominophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Doxylamine Succinate 6.25 mg, Phenylephrine Hydrochloride 5 mg, 40 Liquid Gels, Liquid Filled Capsules, NDC #0280-1195-40. Recall # D-1320-2012;

Lot # NAA04N7, Exp. 09/13; NAA04N8, Exp 01/14

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ, by telephone and letters on March 30, 2012. 

Manufacturer: Bayer HealthCare LLC Consumer Care Division, Myerstown, PA. Firm initiated recall is ongoing.

REASON

Labeling: Labeling Mix-up: The label statement on the blister strip regarding the maximum number of capsules that should be taken within a 24 hour period, does not match the statement on the carton.

PRODUCT

Claravis(TM) (Isotretinoin Capsules, USP) 40 mg, carton containing 3 blister packs of 10 (30 capsules total), NDC #0555-1057-86, Rx only. Recall # D-1325-2012; Lot #33800901A, exp 9/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 8, 2012. 

Manufacturer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.

REASON

Stability data does not support expiration date: This lot of product is being recalled due to a packaging tool that created a slightly larger blister cavity than normal.

Apr 20   FDA Drug Safety Communication: New Warning and Contraindication for Blood Pressure Medicines Containing Aliskiren (Tekturna).  The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes.  In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints.”  For a list of medicines, see: http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm?source=govdelivery

Apr 18   FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems (“Patches”).   Recently, FDA evaluated a series of 26 cases of pediatric accidental exposures to fentanyl patches reported over the past 15 years. Of these 26 cases, ten resulted in death and 12 in hospitalization. Sixteen of the 26 cases occurred in children two years old or younger.  Young children are at particular risk of accidental exposure to fentanyl patches.  Their  mobility and curiosity provide opportunities for them to find lost patches, take improperly discarded patches from the trash, or find improperly stored patches, all of which may result in patches being placed in their mouths or sticking to their skin.  Patients are encouraged to review the fantanyl patch product label for the instructions for use.

Apr 18   Recalls Pending Classification: Drugs

PRODUCT

Claravis ™ (Isotretinoin Capsules, USP) 40 mg, Carton containing 3 blister packs of 10 (30 capsules total), (NDC 0555-1057-86); Lot #33800901A, exp 9/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc. Sellersville, PA

Manufacturer: Barr Laboratories Inc, Pomona, NY

REASON FOR RECALL

Stability data does not support expiration date: Due to the use of a packaging tool that created a slightly larger blister cavity.

PRODUCT

MethylPREDNISolone, Tablets, USP, 4 mg, 21 Count Blister Pack, (NDC 0603-4593-15); Lot Number: S003M11, exp 9/13

RECALLING FIRM/MANUFACTURER

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL

REASON FOR RECALL

Labeling: Label Mix-Up: label is rotated 180 degrees such that there is one tablet in the row for Day 1 that should be 6 tablets and 6 tablets in the row for Day 6 that should be 1 tablet.

Recalls and Field Corrections: Drugs – Class I

PRODUCT

NatureRelief instant wart and mole remover; Just One 15 Minute Application Removes All warts, Moles, Skin tags, And Genital Warts [HPV]; DERMATOLOGIST RECOMMENDED FORMULA FOR MEN & WOMEN; Ingredients; A natural proprietary blend of Garlic (Allum, Sativum), tomato (Lycopersium Esculenium), Calcium Oxide (Cao-Lime), & De-ionized Water. Recall # D-1313-2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Nature Relief, LLC, Miami Beach, FL, by press release on June 22, 2011 and email on July 7, 2011.

Manufacturer: Allium Corp., Artesia, CA. Firm initiated recall is ongoing.

REASON

Marketed Without an approved NDA/ANDA: Nature Relief, Lake Worth, FL is voluntarily recalling NatureRelief Instant Wart and Mole Remover because this product contains calcium oxide (Cao-Lime) which can cause cutaneous chemical burns to the skin. Nature Relief Instant Wart and Mole Remover was distributed in a kit with no NDC or lot control numbers on the packaging.

Apr 18   Recalls and Field Corrections: Drugs – Class II

PRODUCT

Midodrine Hydrochloride Tablets, 5 mg, 100-count tablets per bottle, Rx only, NDC 0185-0043-01, Recall # D-1312-2012; Lot number: BT0643, Exp 06/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz Inc., Princeton, NJ by letters and on/about February 21, 2012 and April 9, 2012 expanding the recall to the retail level.  

Manufacturer: Sandoz Inc., Wilson, NC

REASON

Tablet Thickness: This product is being recalled due to out of specification (above and below) results for tablet weight and above specification for tablet thickness.

PRODUCT

Pramipexole Dihydrochloride Tablets, 0.125 mg, 63-count tablets per bottle, Rx only; NDC 0555-0617-62. Recall # D-1321-2012; Lot #: 314467, 314642, 315467, 315468, Exp 03/12; 317085, 317086, 317218, Exp 08/12; 33800308A, Exp 04/13; 33800780A, 33800781A, Exp 06/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters and e-mail on March 22, 2012. 

Manufacturer: Barr Laboratories Inc., Pomona, NY. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products:  Product may not meet the impurity specification through the 24-month shelf life.

Apr 17    Recalls Pending Classification: Drugs

PRODUCT

Pramipexole Dihydrochloride Tablets, 0.125 mg, Rx only, 90 Tablets: NDC 00781-53248-92; Lot # BJ3186, Exp. 12/12; BJ3142, Exp. 12/12.

 RECALLING FIRM/MANUFACTURER

 Recalling Firm: Sandoz Incorporated

Manufacturer: Sandoz Private Limited

REASON FOR RECALL

Impurities/Degradation Products: Product is being recalled due to an out-of-specification result for known degradant impurity at the 12-month stability time point.

PRODUCT

Alka-Seltzer Plus, Severe Sinus Congestion, Allergy & Cough Formula, 40 Liquid Gels (NDC # 0280-1195-40); Lot Number: NAA04N7, Exp. 09/13; NAA04N8, Exp. 01/14.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ

Manufacturer: Bayer Healthcare LLC Consumer Care Division, Myerstown, PA

REASON FOR RECALL:

Labeling: Label Mix-up: The maximum number of capsules to be taken in 24 hours on the labeling strip does not match the statement on the carton.

PRODUCT

Good Neighbor Pharmacy, Night Time Liquid Caps, acetaminophen, dextromethorphan HBr, doxylamine succinate, Multi Symptom Cold/Flu Relief, 12 softgels per blister cards, NDC 24385-0035-53. Recall # D-1311-2012; Lot Numbers: X05350, X07080, X14328, X17788, and X23422

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pl Developments, Inc., Westbury, NY, by e-mail on February 29, 2012.

Manufacturer: Banner Pharmacaps Inc., High Point, NC. Firm initiated recall is ongoing.

REASON

Labeling: Label Mix-up: Good Neighbor Pharmacy brand Night Time Liquid Caps are being recalled because the labeling states Antihistamine Free when the product contains an antihistamine.

PRODUCT

Midodrine Hydrochloride Tablets, 5 mg, 100-count tablets per bottle, Rx only, NDC 0185-0043-01. Recall # D-1312-2012; Lot number: BT0643, Exp 06/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz Inc., Princeton, NJ, by letter on/about February 21, 1012 and reissued letter on April 9, 2012.

Manufacturer: Sandoz Inc., Wilson, NC. Firm initiated recall is ongoing.

REASON

Tablet Thickness: This product is being recalled due to out of specification (above and below) results for tablet weight and above specification for tablet thickness.

Apr 11   Seroquel (quetiapine) That Treats Symptoms of Schizophrenia Available for First Time as a Generic.  An anti-psychotic drug, quetiapine treats the symptoms of schizophrenia. Quetiapine is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children. However, quetiapine is not approved by the FDA for the treatment of behavioral problems in older adults with dementia.  Quetiapine works by helping to restore the balance of certain natural substances in the brain.  The medication helps decrease hallucinations, improves concentration, and prevents or decreases severe mood swings.  Quetiapine is one of many popular drugs recently approved by the FDA in a generic form. Generic drugs provide safe and effective alternatives to brand name drugs, usually at a lower cost. This approval is an important step in the Agency’s efforts to increase the availability of generic medications.

Apr 11   FDA Has Published a 51 Page List of CDER Guidance Documents.  It can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery

Apr 11   FDA Has Published a 2 Page List of New/Revised/Withdrawn CDER Guidance.  It can be obtained at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM299352.pdf?source=govdelivery

Apr 10   Current Drug Shortages: Norethindrone and Ethinyl Estradiol Tablets, USP (Ovcon 50 Tablets).  Warner Chilcot Customer Service is reporting manufacturing delays with no estimated date of availability.

Apr 4     Recalls and Field Corrections: Drugs – Class II

PRODUCT

Morphine Sulfate ER , Tablets, 200 mg, , Rx only, bottles of 100 count, For use in opioid-tolerant patients only, NDC 0378-2662-01, Recall # D-1283-2012; Lot 2002900 Exp September 2013, Lot 2002901 Exp September 2013, Lot 3035357 Exp January 2014.

RECALLING FIRM/MANUFACTURER

Mylan Pharmaceuticals Inc., Morgantown, WV, by letter on March 9, 2012. Firm initiated recall is ongoing.

REASON

Label: Presence of Undeclared Color Additive; Product outsert indicated Yellow Dye #6, correct nomenclature is Yellow Dye #5.

PRODUCT

Pedia Care Infants Gas Relief Drops (Simethicone), a) Dye-Free/Non-staining Formula, 1fl oz (30ml) UPC Code: 814832011246; b) AntiGas, 1 fl oz (30ml), , UPC Code: 814832011253. Recall # D-1284-2012; numerous lots.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Medtech Products, Inc., Irvington, NY, by letters on March 19, 2012.

Manufacturer: Guardian Drug Co., Dayton, NJ. Firm initiated recall is ongoing.

REASON

Microbial Contamination of Nonsterile Products: possible contamination with Burkholderia cepacia.

PRODUCT

Infants' Tylenol (acetaminophen) Oral Suspension, 160 mg per 5 ml, 1 fl oz. (30 ml) bottle packaged with SimpleMeasure(TM) dosing system, Grape flavor; NDC 50580-191-01; UPC 3 0045-0122-30 8. Recall # D-1285-2012; Lot #: BIL0U00, BIL0V00, BIL3500, Exp 08/13; BJL2D00, BJL2E00, BJL2T00, BJL2U00, Exp 09/13

RECALLING FIRM/MANUFACTURER

Recalling Firm: McNeil Consumer Healthcare, Div Of McNeil-ppc, Inc., Fort Washington, PA, by letter on February 17, 2012. 

Manufacturer: Janssen - Cilag S.p.A., Borgo San Michele, Italy. Firm initiated recall is ongoing.

REASON

Defective Container: Recall Due to Dosing System Complaints.

PRODUCT

Temodar (temozolomide capsules), 5 mg per capsule, 5-count

bottle, Rx Only, Cytotoxic, NDC 0085-3002-02. Recall # D-1293-2012; Lot: 0HLO008

RECALLING FIRM/MANUFACTURER

Schering-Plough Products, LLC, Las Piedras, PR, by letter on February 27, 2012. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: This recall is due to an out of specification result relating to total degradation products detected during stability testing. 

PRODUCT

Cyclosporine Oral Solution, USP (modified), 100 mg/mL, Rx Only, NDC 60505-0354-1. Recall # D-1294-2012; Lot #: JN1053, Exp 06/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Apotex Inc., Toronto, Canada, by letter dated February 3, 2012.

Manufacturer: Apotex Inc., Richmond Hill, Ontario, Canada. Firm initiated recall is ongoing.

REASON

Presence of precipitate; the product may contain a light sediment.

PRODUCT

1) Ropinirole Hydrochloride Tablets, 0.25 mg, 500-count bottle, Rx Only, NDC # 60429-793-05, Recall # D-1286-2012;  Numerous lots. 

2) Ropinirole Hydrochloride Tablets, 0.5 mg, a) 30-count bottle, NDC 60429-794-30, b) 90-count bottle, NDC 60429-794-90, and c) 500-count bottle, NDC 60429-794-05, Rx Only. Recall # D-1287-2012; numerous lots. 

3) Ropinirole Hydrochloride Tablets, 1mg, 500-count bottle, Rx Only, NDC # 60429-795-05. Recall # D-1288-2012; numerous lots. 

4) Ropinirole Hydrochloride Tablets, 2 mg, 500-count bottle, Rx Only, NDC # 60429-796-05. Recall # D-1289-2012; numerous lots.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Golden State Medical Supply Inc., Camarillo, CA, by letters on April 28, 2011 and May 3, 2011.

Manufacturer: Corepharma LLC, Middlesex, NJ. Firm initiated recall is complete.

REASON

Impurities/Degradation Products: The firm initiated this voluntary recall to the retail level due to the potential that the affected lots may not meet the specification for a known impurity over the product shelf life.

Apr 4     Drugs to Be Discontinued: Aminophylline Tablets, USP, 100 mg and 200 mg.  West-Ward Pharmaceutical Corp. has made a business decision to discontinue Aminophylline Tablets.

Mar 30   FDA Continues To Study BPA.   The Food and Drug Administration's assessment is that scientific evidence at this time does not suggest that the very low levels of human exposure to BPA through the diet are unsafe.  BPA It stands for Bisphenol A. It is a chemical used in the production of plastics and resins, such as some water bottles and the coatings of some food cans. It is also used in some consumer goods, such as compact discs and thermal cash register tapes.  And it has generated controversy about its impact on human health and development.  Research has shown that people are exposed to BPA because small amounts can migrate into the food and beverages from their containers. Reports from some animal studies have raised potential concerns that BPA exposure may cause multiple health problems, including reproductive disorders, diabetes and cardiovascular disease.  Here is information for consumers who want to limit their exposure to BPA:

· Plastic containers have recycle codes on the bottom. Some, but not all, plastics that are marked with recycle codes 3 or 7 may be made with BPA.

· Do not put very hot or boiling liquid that you intend to consume in plastic containers made with BPA. BPA levels rise in food when containers/products made with the chemical are heated and come in contact with the food.

·  Discard all bottles with scratches, as these may harbor bacteria and, if BPA-containing, lead to greater release of BPA.

Mar 29   CDC Estimates 1 in 88 Children in United States Has Been Identified as Having an Autism Spectrum Disorder.  The Centers for Disease Control and Prevention estimates that 1 in 88 children in the United States has been identified as having an autism spectrum disorder (ASD), according to a new study released today that looked at data from 14 communities.  Autism spectrum disorders are almost five times more common among boys than girls – with 1 in 54 boys identified.  The number of children identified with ASDs ranged from 1 in 210 children in Alabama to 1 in 47 children in Utah.  The largest increases were among Hispanic and Negro children.  Study results from the 2008 surveillance year show 11.3 per 1,000 8-year-old children have been identified as having an ASD.  This marks a 23 percent increase since the last report in 2009.  To learn more about the research CDC is doing on autism, visit www.cdc.gov/ncbddd/autism/research.html. 

Mar 29   Guidance For Industry: Compliance Policy on Reporting Drug Sample Distribution Information. 

This document can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM297848.pdf?source=govdelivery

Mar 28   Guidance for Industry: Draft Guidance on Iron Sucrose.  This document can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM297630.pdf?source=govdelivery

Mar 26   FDA Considers Expanding Definition of Nonprescription Drugs.  Getting medicines into the hands of consumers has become troublesome over the last few years. Research shows that for a variety of reasons, 20 percent of patients with prescriptions do not get them filled. Also, the time or cost required visiting a doctor to receive a prescription or refill often stops patients.  In addition, OTC products are not covered by insurance which could result in a tremendous saving to the industry.   The Food and Drug Administration thinks that some doctor visits can be eliminated.  It is exploring ways to make drugs for common conditions available as nonprescription products. Under this paradigm, the agency would approve drugs -- that would otherwise require a prescription -- for over-the-counter (OTC) distribution, if certain conditions are followed.  Topping the list of other potential roadblocks, are: liability concerns, disruption of workflow for often overburdened pharmacists, equipment costs, and questions about health insurance reimbursement.  While FDA, consumer groups, health care associations and other Federal government agencies acknowledge potential issues with this new paradigm, most are willing to move forward.

Mar 22   Drug Shortages – Anadrol-50 Tablets (Oxymetholone Tablets).  Meda Pharmaceuticals announced a shortage of Anadrol-50 due to supply shortage of the active pharmaceutical ingredient (API).  Availability of the product is anticipated soon.

Drug Shortages – Oxymorphone Hydrochloride Oral Tablet.   Several companies announced a shortage of this product in all strengths due to increase in market demand and a shortage of active pharmaceutical ingredient (API).  No date for product availability was given.

Mar 21   Recalls Drugs Awaiting Classification

PRODUCT

Ropinirole HCl a) 0.25mg 500-count bottle; b) 0.5mg 30-count bottle; c) 0.5mg 90-count bottle; d) 0.5mg 500count bottle; e) 1mg 500-count bottle; f) 2mg 500-count bottle

CODE

Approximately 30 lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: Golden State Medical Supply Inc., Camarilla, CA

Manufacturer: Corepharma LLC, Middlesex, NJ

REASON FOR RECALL

Impurities/Degradation Products

PRODUCT

Midodrine Hydrochloride Tablets, 5mg, 100-count bottle, NDC 0185-0043-01,

CODE

Lot number: BT0643, Exp Date 06/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz, Inc. Princeton, NJ

Manufacturer: Sandoz Pharmaceuticals, Wilson, NC

REASON FOR RECALL

Rough appearance and legibility of the logo on some of the tablets

Recalls Drugs Class II

PRODUCT

1) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Original (16 fl. oz.) NDC#: 37000-032-04, SKUs 84806240 and 84804290. Recall # D-1271-2012;

2) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Cherry (12 fl. oz.) NDC#: 37000-475-12, SKU 84929877. Recall # D-1272-2012;

3) Pepto Bismol (Bismuth subsalicylate upset stomach reliever/antidiarrheal), Max Strength (12 fl. oz.) NDC#: 37000-019-03, SKUs 80216951 and 80216952. Recall # D-1273-2012

CODE

Numerous

RECALLING FIRM/MANUFACTURER

Procter & Gamble Co., Mason, OH, by letter on March 12, 2012.

Manufacturer: Procter & Gamble Manufacturing, Greensboro, NC. Firm initiated recall is ongoing.

REASON

Microbial Contamination of Non-Sterile Products: Out of Specification (OOS) result for Purified Water used to rinse product contact parts during manufacturing.

PRODUCT

Clonidine Transdermal System, USP 0.2 mg/day, 4 patches/carton, Rx only, NDC 0378-0872-99. Recall # D-1268-2012

CODE

Lot Number: 6C0074 Expiration June 2013

RECALLING FIRM/MANUFACTURER

Mylan Technologies, Inc., Saint Albans, VT, by letter beginning on February 24, 2012. Firm initiated recall is ongoing.

REASON

Defective Delivery System: Mechanical Peel Force yielded high OOS results.

Mar 21   On March 27, 2012, at 11.00 a.m., FDA will present a webinar on a new draft guidance entitled "Determining the extent of safety data collection needed in late stage premarket and postapproval clinical investigations." The docket number is FDA-2012-D-0096.  To access the draft guidance, visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291158.pdf  

Information about the draft guidance and webinar can be found at http://www.fda.gov/Drugs/ucm273272.htm   

Mar 19  FDA approves first Boniva generics to treat or prevent osteoporosis.  The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause. Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram ibandronate tablets. 

Mar 19   Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases.  FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events.  The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S.

Mar 16  Recently Posted Guidance Documents:                                                                                                     1.  Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

2.  Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

3.  Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

Mar 14   Recalls Class III

PRODUCT  

Flutamide Capsules USP, 125 mg, Rx, 180-count bottle, NDC 0172-4960-58. Recall # D-1267-2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on January 24, 2012.

Manufacturer: Cipla Ltd, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.

REASON

Adulterated Presence of Foreign Capsule; The firm received a complaint that a Flutamide 125 mg capsule, 180-count bottle had a foreign capsule identified as Imatinib Mesylate 100 mg capsule.

Mar 14   Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing  The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. The purpose of this hearing is to solicit public input on FDA’s efforts to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP), including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise.                                                                         Date(s):     April 23-24, 2012    Time:          8:30 a.m. to 4:30 p.m.  Location:    FDA White Oak Campus, 10903 New Hampshire Ave.  Building 31, Room 1503   Silver Spring, Maryland 20993

Webcast of Meeting.  For those unable to attend in person, the meeting will also be webcast. Watch the webcast on April 23 and April 24 from 8:30 am to 4:30 pm. Requirements and instructions for accessing the webcast are below.                                                                                                                                                       Adobe Connect Minimum Requirements:                                                                                          View meetings on Windows, Macs, Unix, and Linux platforms                                                               Lan or Broadband internet connection                                                                                         Support, s Internet Explorer, Firefox, Safari, Netscape Navigator, AOL                                            Adobe Flash Player (no other downloads needed)                                                                                             VPN and Parachute compatible but not required                                                                                     Individuals who wish to present at the public hearing must register on or before April 2, 2012, through the email ClinTrialPublicMt@fda.hhs.gov.

Mar 9     Warning Letter Issued to Laboratorios JJaloma S.A. de CV in Jalisco, Guadalajara, Mexico.

               The FDA identified significant violations of current good manufacturing practice (CGMP) regulations contained in Title 21, Code of Federal Regulations, Parts 210 and 211, including but not limited to failure to perform laboratory identity and strength testing on finished products because they do not have the required instrumentation, incomplete laboratory records, no stability testing, no validation of manufacturing processes, and no written production and control procedures to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess..

Mar 8    Guidance – How FDA Communicates, Prioritizes Drug Safety Issues,   You can read this guidance at: http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm295285.htm?source=govdelivery

            Guidance – Drug Safety Information – FDA’s Communication to the Public.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295217.pdf?source=govdelivery 

Mar 14   Recalls Class III

PRODUCT  

Flutamide Capsules USP, 125 mg, Rx, 180-count bottle, NDC 0172-4960-58. Recall # D-1267-2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on January 24, 2012.

Manufacturer: Cipla Ltd, Verna, Salcette, Goa, India. Firm initiated recall is ongoing.

REASON

Adulterated Presence of Foreign Capsule; The firm received a complaint that a Flutamide 125 mg capsule, 180-count bottle had a foreign capsule identified as Imatinib Mesylate 100 mg capsule.

Mar 14   Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing  The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products. The purpose of this hearing is to solicit public input on FDA’s efforts to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP), including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise.                                                                         Date(s):     April 23-24, 2012    Time:          8:30 a.m. to 4:30 p.m.  Location:    FDA White Oak Campus, 10903 New Hampshire Ave.  Building 31, Room 1503   Silver Spring, Maryland 20993

Webcast of Meeting.  For those unable to attend in person, the meeting will also be webcast. Watch the webcast on April 23 and April 24 from 8:30 am to 4:30 pm. Requirements and instructions for accessing the webcast are below.                                                                                                                                                Adobe Connect Minimum Requirements:                                                                                          View meetings on Windows, Macs, Unix, and Linux platforms                                                                    Lan or Broadband internet connection                                                                                                  Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL                                            Adobe Flash Player (no other downloads needed)                                                                                        VPN and Parachute compatible but not required                                                                           Individuals who wish to present at the public hearing must register on or before April 2, 2012, through the email ClinTrialPublicMt@fda.hhs.gov.

Mar 9     Warning Letter Issued to Laboratorios JJaloma S.A. de CV in Jalisco, Guadalajara, Mexico.

               The FDA identified significant violations of current good manufacturing practice (CGMP) regulations contained in Title 21, Code of Federal Regulations, Parts 210 and 211, including but not limited to failure to perform laboratory identity and strength testing on finished products because they do not have the required instrumentation, incomplete laboratory records, no stability testing, no validation of manufacturing processes, and no written production and control procedures to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess..

Mar 8    Guidance – How FDA Communicates, Prioritizes Drug Safety Issues,   You can read this guidance at: http://www.fda.gov/Drugs/ResourcesForYou/SpecialFeatures/ucm295285.htm?source=govdelivery

            Guidance – Drug Safety Information – FDA’s Communication to the Public.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295217.pdf?source=govdelivery 

Mar 8     Guidance – Classifying Significant Postmarketing Drug Safety Issues.   This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM295211.pdf?source=govdelivery

Mar 8     Drug Shortages – Caffeine and Ergotamine Tartrate Tablet.  Sandoz Customer Service reports that the shortage is due to a change in the raw material plant location.  Sandoz cannot estimate an availability date.

Mar 7     Warning Letter Issued Nobilus Ent in Kutno, Poland.  The FDA identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs causing the APIs they manufacture to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.  Specifically, the firm failed to use dedicated production areas, including facilities, air handling equipment, and process equipment when manufacturing APIs. 

Mar 5     New & Revised Draft Guidances that CDER is Planning to Publish During Calendar Year 2012.  CDER will publish 52 guidances this year to further increase the regulatory burden on the pharmaceutical industry.  You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079647.pdf?source=govdelivery

Mar 5     Guidance - Acceptance of Foreign Studies Not Conducted Under and IND.  You can download it at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf?source=govdelivery

Mar 3     Guidance for IRBs, Clinical Investigators, and Sponsors - IRB Continuing Review After Clinical Investigation Approval.   You can download this guidance at:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf?source=govdelivery

Mar 2    Guidance for Industry:  Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.  You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM294086.pdf?source=govdelivery

Feb 29    Recalls Class I

               PRODUCT

Excedrin Tension Headache (acetaminophen 500 mg, caffeine 65 mg) Caplets, packaged in a) 100-count bottles (NDC 0067-2045-91), b) 125-count bottles (NDC 0067-2045-84), c) 250-count bottles (NDC 0067-2045-07). Recall # D-1219-2012

CODE

Lot #: a) 10087530, Exp. 3/31/2013; b) 10089902, Exp. 4/30/2013; c) 10063947, Exp. 11/30/2011

RECALLING FIRM/MANUFACTURER

Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on January 8, 2012. Firm initiated recall is ongoing.

REASON

Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the products.

Feb 29    Recalls Class II

               PRODUCT

1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Tablets, packaged in a) 100-count bottles (NDC 0067-2030-91), b) 250-count bottles (NDC 0067-2030-77), and c) 300-count bottles (NDC 0067-2030-33). Recall # D-1220-2012;                                                     2) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Express Gels gelcaps, packaged in 80-count Gelcaps per bottle, NDC 0067-6270-94. Recall # D-1221-2012;

3) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2039-24. Recall # D-1222-2012;

4) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2000-24. Recall # D-1223-2012;

5) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Tablets, packaged in 250-count bottles, NDC 0067-2037-77. Recall # D-1224-2012

CODE

1) Lot #: a) 10091817, Exp. 5/31/2013; b) 10092843, Exp. 6/30/2013; and c) 10073080, Exp. 6/30/2012;

2) Lot #10089353, Exp. 04/30/12;

3) Lot #: 10066070, 10066069, Exp. 1/31/2012; 10074660, Exp. 7/31/2012; 10101757, Exp. 10/31/2013; 10102541, Exp. 11/30/2013;

4) Lot #: 10085080, Exp. 1/31/2013;

5) Lot #: 10086758, Exp 2/28/2013; 10092845, Exp 6/30/2013

RECALLING FIRM/MANUFACTURER

Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on January 8, 2012. Firm initiated recall is ongoing.

REASON

Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the products.

               PRODUCT

1) Topiramate Tablets, 25 mg, a) NDC 0093-0155-10 (1000 count) and b) NDC 0093-0155-06 (60 count). Recall # D-1225-2012;

2) Topiramate Tablets, 200 mg, NDC 0093-7220-06 (60 count). Recall # D-1226-2012

CODE

1) a) Lot # 28T027, exp 1/2012; b) Lot # 28T030, exp 1/2012;

2) Lot # 16T020, exp 1/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 22, 2011.

Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: High OOS results for Impurity.

PRODUCT

1) Bufferin Extra Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 500 mg, packaged in a) 39-ct. (NDC 0067-2065-39); and b) 130-ct. bottles (NDC 0067-2065-13). Recall # D-1227-2012;

2) Bufferin Buffered Aspirin (NSAID) Low Dose (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 81 mg, 130-ct. bottles; NDC 0067-6424-13. Recall # D-1228-2012;

3) Bufferin Regular Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 325 mg, 130-ct. bottles; NDC 0067-2063-13. Recall # D-1229-2012;

4) Excedrin Back & Body Extra Strength (acetaminophen 250 mg and aspirin 250 mg buffered with calcium carbonate) bi-layer caplets, packaged in a) 24-ct. bottles (NDC 0067-6238-24); b) 50-ct. bottles (NDC 0067-6238-50); and c) 100-ct. bottles (NDC 0067-6238-91 and NDC 0067-6238-94). Recall # D-1230-2012;

5) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2000-24); b) 30-ct. (24-ct. + 6-ct. bonus) bottles (NDC 0067-2000-30); c) 50-ct. bottles (NDC 0067-2000-50); d) 100-ct. bottles (NDC 0067-2000-91 and NDC 0067-2000-94); e) 125-ct. (100-ct. + 25-ct. bonus) bottles (NDC 0067-2000-83, NDC 0067-2000-84, and NDC 0067-2000-86); f) 250-ct. bottles (NDC 0067-2000-07 and NDC 0067-2000-77); g) 300-ct. (250-ct. + 50-ct. bonus) bottles (NDC 0067-2000-55). Recall # D-1231-2012;

6) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6270-20); b) 40-ct. bottles (NDC 0067-6270-40); and c) 80-ct. bottles (NDC 0067-6270-80 and NDC 0067-6270-94). Recall # D-1232-2012;

7) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) geltabs, 24-ct. bottles. Recall # D-1233-2012;

8) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, packaged in a) 8-ct. bottles (NDC 0067-2030-08); b) 24-ct. bottles (NDC 0067-2030-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2030-30); d) 50-ct. bottles (NDC 0067-2030-50); e) 100-ct. bottles (NDC 0067-2030-91 and NDC 0067-2030-94); f) 125-ct. bottles (100-ct + 25-ct. bonus) (NDC 0067-2030-83 and NDC 0067-2030-86); g) 200-ct. bottles (NDC 0067-2030-92); h) 250-ct. bottles (NDC 0067-2030-07 and NDC 0067-2030-77); i) 300-ct bottles (250-ct + 50-ct. bonus) (NDC 0067-2030-55 and NDC 0067-2030-57); j) 300-ct. bottles (NDC 0067-2030-33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2423 33 7). Recall # D-1234-2012;

9) Excedrin Menstrual Complete Express Gels (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) gelcaps, 20-ct. bottles; NDC 0067-6341-20. Recall # D-1235-2012;

10) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, packaged in a) 8-ct. bottles (NDC 0067-2039-08); b) 24-ct. bottles (NDC 0067-2039-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2039-30); d) 50-ct. (NDC 0067-2039-50); e) 100-ct. bottles (NDC 0067-2039-91 and NDC 0067-2039-94); f) 125-ct. bottles (100-ct + 25-ct. bonus) (NDC 0067-2039-84, NDC 0067-2039-86, and NDC 0067-2039-83); g) 200-ct. bottles (NDC 0067-2039-92); h) 250-ct. bottles (200-ct. + 50-ct. bonus) (NDC 0067-2039-55 and 0067-2039-57); i) 250-ct. bottles (NDC 0067-2039-07 and NDC 0067-2039-77); j) 300-ct. bottles (NDC 0067-2039-33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2424 33 4). Recall # D-1236-2012;

11) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) geltabs, packaged in a) 24-ct. bottles (NDC 0067-2035-24); b) 50-ct. bottles (NDC 0067-2035-50); c) 100-ct. Twin Pack carton containing [2 x 50-ct. bottles (NDC 0067-2035-50)] (carton NDC 0067-2035-91 and 0067-2035-93); d) 160-ct. Twin Pack carton containing [2 x 80-ct. bottles (NDC 0067-2035-80)] (carton NDC 0067-2035-16). Recall # D-1237-2012;

12) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, packaged in a) 24-ct. bottle (NDC 0067-2037-24); b) 30-ct. bottle (24-ct. + 6-ct. bonus) (NDC 0067-2037-30); c) 50-ct. bottle (NDC 0067-2037-50); d) 100-ct. bottle (NDC 0067-2037-91; e) 125-ct. bottle (100-ct. + 25-ct. bonus) (NDC 0067-2037-83; f) 250-ct. bottle (NDC 0067-2037-77). Recall # D-1238-2012;

13) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2055-24); b) 50-ct. bottles (NDC 0067-2055-50); c) 100-ct. bottles (NDC 0067-2055-91); and d) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2055-86). Recall # D-1239-2012;

 14) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6405-20); and b) 80-ct. bottles (NDC 0067-6405-80 and NDC 0067-6409-80). Recall # D-1240-2012;

 15) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) tablets, packaged in a) 8-ct. bottles (NDC 0067-2053-08); b) 24-ct. bottles (NDC 0067-2053-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2053-30); d) 50-ct. bottles (NDC 0067-2053-50); e) 100-ct. bottles (NDC 0067-2053-91 and NDC 0067-2053-94); f) 125-ct. (100-ct. + 25-ct. bonus) (NDC 0067-2053-83). Recall # D-1241-2012;

16) Excedrin Sinus Headache (acetaminophen 325 mg and phenylephrine HCl 5 mg) caplets, 24-ct. bottles; NDC 0067-2062-24. Recall # D-1242-2012;

17) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2045-24); b) 30-ct. (24-ct. + 6-ct. bonus) (NDC 0067-2045-30); c) 50-ct. bottles (NDC 0067-2045-50); d) 100-ct. bottles (NDC 0067-2045-91 and NDC 0067-2045-94); e) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2045-83 and NDC 0067-2045-84); and f) 250-ct. bottles (NDC 0067-2045-77 and NDC 0067-2045-07). Recall # D-1243-2012;

18) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6272-20); b) 40-ct. bottles (NDC 0067-6272-40); and c) 80-ct. bottles (NDC 0067-6272-94). Recall # D-1244-2012;

19) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) geltabs, 24-ct. bottles; NDC 0067-2050-24. Recall # D-1245-2012;

20) Gas-X Prevention [alpha-galactosidase enzyme (aspergillus niger)] capsules, 600 GALU, packaged in a) 20-ct. bottles (UPC 30043-3005-208) and b) 50-ct. bottles (UPC 30043-3005-505). Recall # D-1246-2012;

21) Maximum Strength NoDoz (caffeine) coated caplets, 200 mg, packaged in a) 16-ct. bottles (NDC 0067-2070-16); b) 36-ct. bottles (NDC 0067-2070-36); and c) 60-ct. bottles (NDC 0067-2070-60). Recall # D-1247-2012

CODE

All lots that bear expiration date of 12/20/13 or earlier and all lots that bear expiration date of 12/20/14 or earlier.

RECALLING FIRM/MANUFACTURER

Novartis Consumer Health, Lincoln, NB, by press release, telephone and letters on January 8, 2012 and letters on January 9, 2012. Firm initiated recall is ongoing.

REASON

CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's.

PRODUCT

1) Ventolin HFA (albuterol sulfate) 90 mcg per actuation a) 60 Actuations, NDC 0173-0682-21; b) 60 Actuations Sample, NDC 0173-0682-23; c) 60 Actuations Institutional Pack, NDC 0173-0682-24 Rx only. Recall # D-1252-2012;

2) Ventolin HFA Inhaler (albuterol sulfate) 90 mcg per actuation NOVAPLUS - 60 Actuations, Rx only, NDC 0173-0682-54. Recall # D-1253-2012

CODE

1) Lot: 1ZP0922, 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, 1ZP8151, 1ZP0856, 1ZP1981, 1ZP6941, 1ZP7824, 1ZP9063;

   2) Lot numbers: 1ZP1061, 1ZP6940 and 1ZP9680

RECALLING FIRM/MANUFACTURER

GlaxoSmithKline Inc., Zebulon, NC, via letter on/about January 18, 2012. Firm initiated recall is ongoing.

REASON

Does Not Deliver Proper Metered Dose: The affected canisters may not contain sufficient propellant to deliver the labeled claim of 60 doses.

PRODUCT

Bupropion Hydrochloride Extended-Release Tablets (XL), 150mg tablets,150mg, packaged in 10-count UD tablets (NDC #68084-251-11), 10 x 10-count tablets per box (NDC 68084-251-01) Rx only, Recall # D-1248-2012

CODE

AHP Lot 110564, Exp. Date 03/31/2012; AHP Lot 103077, Exp. Date 03/31/2012; AHP Lot 103499, Exp. Date 06/30/2012 & AHP Lot 110450, Exp. Date 03/31/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Health Packaging, Columbus, OH, by letters on January 18, 2912.  

Manufacturers: Actavis South Atlantic LLC. Sunrise, FL;

CMIC CMO USA Corp., Cranbury, NJ. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Requirements: American Health Packaging was notified by their supplier that the product is being recalled due to possible out-of-specification dissolution results for 8-hours stability testing point.

Feb 28    Guidance for Industry Size of Beads in Drug Products Labeled for Sprinkle.  You can download this guidance at: 

    http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243.pdf?source=govdelivery

Feb 27    Final Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents

               FDA is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ‘‘Q3C Impurities: Residual Solvents.’’  Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-02-23/pdf/2012-4164.pdf

Feb 26    Glenmark Generics Inc. Announces a Nationwide Recall of Seven (7) Lots of Norgestima​te and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg (Generic) Due to Possibility of Out of Sequence Tablets.  The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch. Any blister for which the lot number and expiry date is not visible is subject to recall. This packaging error is limited to the seven (7) lots listed in the table below of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. This product is used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy.  Lot numbers are 041101 01, 06, 07, 14, 24, 29, and 04110134.

These tablets were manufactured and packaged by Glenmark Generics Ltd. India. and are distributed by Glenmark Generics Inc. USA. This product is distributed to wholesalers and retail pharmacies nationwide between September 21, 2011 and December 30, 2011. This product is distributed by Glenmark Generics Inc. only in the USA. 

Feb 24    Regeneca, Inc. Issues a Voluntary Nationwide Recall of All Lots of Single Capsule RegenErect Because of Potential Health Risks.  Regeneca, Inc. (Pink Sheets: RGNA) announced today that it is conducting a voluntary nationwide recall of all lots of single capsule packet RegenErect, labeled as a dietary supplement. The company, through independent lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products. Use of these products may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Feb 23    Warning Letter issued to Wintac Limited in Basavanagudi, Bangalore, India.  FDA identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211.  Wintac was cited for not having established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.  Also, Wintac has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed.  Batch production and control records do not include complete information related to the production and control of each batch produced

 Feb 22   Recalls – Drugs Class II

PRODUCT

1) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID), 24 Coated Tablets, NDC 50580-109-02. Recall # D-1216-2012;

 2) Motrin IB, Ibuprofen Tablets USP 200 mg, Pain Reliever/Fever Reducer (NSAID),24 Coated Caplets, NDC 50580-110-03. Motrin IB***Ibuprofen Tablets, USP 200 mg*** 24+6 Coated Caplets***. Motrin IB 24 Count Coated Caplets, Motrin IB 24+6 Coated Caplets. Cartons of Motrin IB Coated Caplets were also included in the following displays: TYl ES/PM CAP 24s, Motrin CAP 24s CU (Display case UPC# 30300450753312); Tylenol Caplet 24/Motrin Caplet 24 (Display case UPC# 30300450749230); Tylenol RRG/PM 24s, Motrin CAP 24s CU (Display case UPC# 30300450754821); and TYl ES/PM/RRG/MOT IB/PM 24s DIST PK (Display case UPC# 30300450755873). Recall # D-1217-2012

CODE

Too numerous to mention here.

RECALLING FIRM/MANUFACTURER

Recalling Firm: McNeil Consumer Healthcare, Div Of McNeil-ppc, Inc, Fort, Washington, PA, by letter and WEB posting on December 21, 2011.

Manufacturer: Dr. Reddy's Laboratories Louisiana LLC, Shreveport, LA. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Test Requirements: McNeil is recalling these products because testing of product sample showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

Feb 18   Public Notifications.   “Hard Ten Days” and “Man King” Each Contain Undeclared Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Hard Ten Days” or “Man King” products for sexual enhancement sold on various websites. FDA laboratory analysis confirmed that these products contain sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED).

Feb 17    Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints.  McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.  Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States.

Feb 16    Spinbrush Powered Toothbrush by Arm and Hammer or Crest: Safety Communication - Choking Hazard and Serious Injuries.   FDA notified parents, caregivers, consumers, and dental care professionals about reports of serious injuries and potential hazards associated with the use of all models of the Spinbrush. These reports indicated that while turned on, the brush head has either “popped off” or broken off in the user’s mouth or near the face, causing cuts to the mouth and gums, chipped or broken teeth, swallowing and choking on the broken pieces, and injuries to the face and eyes. When the unexpected release of any part of the powered toothbrush occurs, there is a potential for serious injury. This risk is higher for unattended children or adults who may need assistance while using this device.  The Spinbrush line of powered toothbrushes is currently sold as the Arm & Hammer Spinbrush and until 2009 was sold as the Crest Spinbrush. The Spinbrush line is manufactured by Church & Dwight Co., Inc.

Feb 14   Drug Shortage – Naltrexone Oral Tablets.  Mallinckrodt announced that supply recovery continues but backorders will continue until mid-April duce to lack of supply of raw material.

Feb 14    Counterfeit Version of Avastin in U.S. Distribution.   The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States.  Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.                        , ;              In a related action, FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin.  The counterfeit version is labeled as Avastin, manufactured by Roche. Roche is the company that manufactures Avastin approved for marketing outside of the United States.                                                                                           Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.  Packages or vials may be counterfeit if they:                                                                                                                                                 …are labeled with Roche as the manufacturer                                                                                      …display batch numbers that start with B6010, B6011 or B86017                                          The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials.  In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).  Genentech’s Avastin products are safe and effective for their intended uses.

   The 19 medical practices in the United States purchased unapproved cancer medicines and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions.  Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.  FDA has requested that the medical practices stop using any remaining products from these suppliers.  FDA cannot ensure the safety or efficacy of any of these unapproved products.

Feb 9     Guidance for Industry – Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations.  You can download this guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291158.pdf?source=govdelivery

Feb 9      FDA issues three draft guidance on biosimilar product development.  The purpose of these documents is to create an abbreviated approval pathway -- under section 351(k) -- for biological products that are demonstrated to be highly similar (biosimilar) to or interchangeable with an FDA-licensed biological product.  To download copies and obtain more information go to:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291232.htm?source=govdelivery  

Feb 9      FDA Issues Guidance on New Informed Consent Requirements.  FDA has issued the guidance, “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)."  This guidance is intended to help sponsors, investigators and Institutional Review Boards better understand the new informed consent requirement set forth in 21 CFR 50.25(c). The guidance will assist those involved in applicable FDA-regulated clinical trials better understand the new informed consent requirement, including small businesses.  The document is now available using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf  

Feb 8      Drug Shortages - Voltaren Gel 1% (Diclofenac Sodium Topical Gel).   Novartis announced that there has been a manufacturing delay for this product.  It is not related to the efficacy or safety of the product.

Feb 8      Recalls – Drugs Class III 

               PRODUCT

Xanax, alprazolam tablets, USP, 0.5 mg, 100 Tablets, Rx only, NDC 0009-0055-01. Recall # D-1197-2012

CODE

Lot: C081196

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pfizer Us Pharmaceutical Group, New York, NY, by letters on January 17, 2012.
Manufacturing Firm 1: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Test Requirements: Stability testing yielded an out-of-specification result for assay at the 36 month stability testing time point.

Feb 8      Warning Letter Issued to Tree Top, Inc., Selah, Washington 98942.  FDA found excessive levels of inorganic arsenic in samples of pear juice taken during an inspection of their facility,.  Inorganic arsenic is a toxic substance and prolonged exposure to high levels of inorganic arsenic is associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans.  The warning letter stated that Tree Top’s Director of Quality and Food Safety responded to a call from the FDA that based on your firm’s assessment Tree Top, Inc. would not take any action as your firm believed that all the material in question had already been consumed.  The warning letter also stated that

               “You should investigate and determine the causes of the violations listed above and take prompt actions to correct the violations and to bring your products into compliance. Failure to promptly correct these violations and implement lasting corrective action may result in FDA taking regulatory action, such as seizure or injunction, without further notice”.

Jan 25   Recalls – Drugs Class II

               PRODUCT

Fluoxetine Capsules USP 10 m, g, Rx only, 1000 Capsules, NDC 0781-2823-10. Recall # D-1177-2012

CODE

Lot BR7539

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on January 5, 2012.

Manufacturer:   Sandoz, Inc., Broomfield, CO. Firm initiated recall is ongoing.

REASON

Microbial contamination of non-sterile product (gelatin capsules contamination).

PRODUCT

Fluoxetine Capsules USP 10 mg, Rx only, 1000 Capsules, NDC 0781-2823-10. Recall # D-1177-2012

CODE

Lot BR7539

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on January 5, 2012.

Manufacturer:   Sandoz, Inc., Broomfield, CO. Firm initiated recall is ongoing.

REASON

Microbial contamination of non-sterile product (gelatin capsules contamination).

Jan 24    Guidance for Industry – Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070076.pdf?source=govdelivery

Jan 19    Recalls – Class II

PRODUCT Fluoxetine Capsules USP, 20 mg, 100-count capsules per bottle, Rx only, NDC 0781-2822-01.  Recall # D-1170-2012 Lot BU9661, Exp 06/14

RECALLING FIRM/MANUFACTURER

Sandoz Inc., Broomfield, CO, by letter on January 6, 2012. Firm initiated recall is ongoing.

REASON

CGMP Deviations: The batch was not manufactured utilizing Good Manufacturing Processes.

PRODUCT 1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 100-count caplets per bottle, NDC 0067-2000-91, UPC 3 0067-2000-91 0. Recall # D-1173-2012; Lot 10068948, Exp 03/12;

2) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 250-count caplets per bottle, NDC 0067-2039-07, UPC 3 0067-2039-07 1. Recall # D-1174-2012; Lot 10084053, Exp 12/12

RECALLING FIRM/MANUFACTURER

Novartis Consumer Health, Lincoln, NE, by letters dated September 6, 2011 via overnight mail, e-mail, Rapid Recall Exchange, or hand-delivered. FDA initiated recall is ongoing.

REASON

Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.

PRODUCT Ramipril Capsules 1.25 mg, 100-count bottles, Rx only, Code No. GO/DRUGS/654. Recall # D-1175-2012; Batch 3904946, Exp 10/11

RECALLING FIRM/MANUFACTURER

Recalling Firm: Lupin Pharmaceuticals Inc., Baltimore, MD, by letter and telephone on August 17, 2011.

Manufacturer: Lupin Limited, Goa, India. Firm initiated recall is ongoing.  

REASON

Subpotent; 24 month stability time point.

PRODUCT 1) Nifedipine Extended Release Tablets, 60 mg, 100 Tablets, NDC: 63739-452-10, Rx only.  Recall # D-1171-2012; Lot number: 00074901; PharmaVOICE | January 2012

2) Nifedipine Extended Release Tablets, 30 mg, 100 tablets, Rx only, NDC 63739-451-10. Recall #             D-1172-2012; Lot number: 00074888

RECALLING FIRM/MANUFACTURER

Recalling Firm: McKesson Packaging Services, Concord, NC, by letter on/about December 15, 2011.

Manufacturer: Aptalis Pharma Inc., Vandalia, OH. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Test Requirements (below specification). 

Jan 17    Warning Letters:

              Natural Health Team of Lacombe, LA   On December 28, 2011, FDA sent a warning letter because 13 of their products are being promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.  Claims on Natural Health Team’s website and in Dr. Howensine”s book establish these products to be drugs because they are intended for use in the cure,          mitigation, treatment, for prevention of disease

               Agora Publishing of Baltimore, MD    On January 12, 2012, FDA sent a warning letter because two of their products are being promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.  Claims on their website establish these products to be drugs because they are intended for use in the cure, mitigation, treatment, for prevention of disease.

Jan 17    CDER Small Business Update – Electronic Source Documentation in Clinical Trials Webinar.       On Monday, January 23, 2012 at 11am (ET), FDA will present our Webinar entitled Electronic Source Documentation in Clinical Trials, which will review regulatory requirements for electronic records and signatures when used in Clinical Investigations and provide practical concerns to keep in mind when preparing for and performing Clinical Investigations.  Registration website (paste into your browser): https://collaboration.fda.gov/sba1/event/registration.html

               Web Address at time of viewing: https://collaboration.fda.gov/sba1/event/login.html

               Call in numbers (listen only):

                        Domestic: 1-888-946-6301

                        International: 1-312-470-0190

                        Password (verbal): FDA

                        For More Information: http://www.fda.gov/smallbusinessdrugs

                        Click on Workshops and Webinars in Spotlight box

Jan 12    Drug Shortages:

               Amphetamine Mixed Salts Immediate-Release Tablets.  Sandoz, CorePharma, and Teva all state that increased demand has caused a shortage of this product.  All three companies will release the product as it becomes available.

               Dextroamphetamine Tablets   Teva Pharmaceuticals claims that manufacturing delays have caused a shortage of this product.  The 5 mg and 10 mg strengths will be on back order through mid-2012.

Jan 12    Recalls – Class II

            PRODUCT    Ovcon 50 (Norethindrone and ethinyl estradiol ) Tablets, 1 mg/50 mcg, USP, NDC #0430-    0585-45, (Trade) NDC #04300585-95 (Sample). Recall # D-1166-2012; Lots 02260F, 504705A,                 504705B (Sample)

            RECALLING FIRM/MANUFACTURER

            Warner Chilcott Company LLC, Fajardo, PR, by letter dated December 30, 2011. FDA initiated recall is ongoing.

            REASON

            Subpotent (Multiple Ingredient Drug) 

Jan 12    Recalls – Class III

               PRODUCT    1) Maalox Advanced Maximum Strength Antacid & Anti-gas, 2) Premium Liquid Maalox                Nighttime, 3) Extra Strength Stomak-Care Multi Action, Bismuth Subsalicylate Suspension, 4) Buckley's                Complete,

               RECALLING FIRM/MANUFACTURER

               Novartis Consumer Health, Lincoln, NB, by letters dated September 12, 2011 and September 13, 2011.       Firm initiated recall is ongoing. 

               REASON

               Presence of Foreign Substance; a small amount of non-USP water leaked into the batches due to a seal                    breach on a pump.

               PRODUCT   1) Ondansetron Hydrochloride Tablets, 4 mg, 1 Card x 3 Tablets per carton, Rx only, NDC                0093-0233-33. Recall # D-1151-2012; Lot # Y04033, Exp 12/12;

               2) Ondansetron Hydrochloride Tablets, 8 mg, 1 Card x 3 Tablets per carton, Rx only, NDC 0093-7236-33.                Recall # D-1152-2012; Lot # Y05037, Exp 05/13

               RECALLING FIRM/MANUFACTURER

               Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 28, 2011. 

               Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.

               REASON

               Labeling: Incorrect or Missing Package Insert: Packages contain out-dated product inserts.

PRODUCT   Ciclopirox Gel, 0.77%, 45 gram tube, Rx Only, UPC 3 0574-2061-45 7, NDC # 0574-2061-45. Recall # D-1165-2012; Lot #: 2010433330, Exp. 10/12; 2011155328, Exp. 04/13

RECALLING FIRM/MANUFACTURER

Paddock Laboratories, Inc., Minneapolis, MN, by letter dated December 16, 2011. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: Two lots did not conform to product specifications for an unspecified impurity at the 9 month stability test station.

Jan 11   Generic Drugs: Information for Industry (updated).  News and Announcements

·         For the submission of Form FDA 3500A reports (15-day Alert Reports and Periodic Adverse Drug Experience Reports) to ANDAs, continue to send these to the following address:                         

·         Central Document Room
5901-B Ammendale Road
Beltsville MD 20705-1266
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM                                                                                                     

·         The new address for all submissions (Abbreviated New Drug Applications (ANDAs), ANDA amendments, ANDA supplements and resubmissions) effective August 1, 2010 is:                               Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Metro Park North VII
7620 Standish Place
Rockville, MD 20855
Hours of Operation:
Monday thru Friday 7:00AM - 6:00PM http://www.hhs.gov/news/newmedia/index.html

Jan 11    Transcript of the Public Meeting on Proposed Recommendations for a Human Generic Drug User Fee Has Been Released.   FDA would like to raise $299 million (inflation adjusted) each year for the next 5 years from generic application fees and generic facility fees.   The transcript can be downloaded at:  http://www.fda.gov/downloads/Drugs/NewsEvents/UCM286660.pdf?source=govdelivery

Jan 10    HHS commits nearly $1.8 million to health initiatives in Guatemala and to improving global human research protections.   The U.S. Department of Health and Human Services will invest approximately $1.8 million to increase its efforts to improve the treatment and prevention of HIV and other sexually transmitted diseases (STD) in Guatemala and to further strengthen ethical training on human research protections.  Building on existing work by HHS agencies, these new activities are part of the Obama Administration's commitment to ensuring that the United States has the strongest possible human subject protections at home and around the world.  Read more at:  http://www.hhs.gov/news/press/2012pres/01/20120110a.html

Jan 9      Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

               Including the following products:

               Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII

               Opana (oxymorphone hydrochloride) CII

               Oxymorphone hydrochloride Tablets CII

               PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII

               PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII

               ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII

               ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII

               MORPHINE SULFATE Extended-Release Tablets CII

               ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

               FDA is advising healthcare professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site. Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product. This could result in a stray pill of one medicine ending up in the bottle of another product.  Learn more: https://mail.google.com/mail/?shva=1#inbox/134c342e107046fa 

Jan 9      Novartis Consumer Health Inc. Issues Voluntary Nationwide Recall of Certain Over-The-Counter      Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps.  Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.  Details at: http://www.fda.gov/Safety/Recalls/ucm286240.htm?source=govdelivery  

Jan 8      PRODUCT   1) Chlorpap PEH DM, IMMEDIATE-RELEASE TABLET, NDC 29273-0104-01. Recall #D-1135-2012; Lot 09G009;

2) Chlorpap PSE, IMMEDIATE-RELEASE TABLET, NDC 29273-0101-01.  Recall # D-1136-2012; Lot 09G002;  

               3) Chlorpap PSE DM, IMMEDIATE-RELEASE TABLET, NDC 29273-0102-01 Recall # D-1137-2012;

               Lot 09G005;

               4) Maxichlor DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0448-01.  Recall # D-         1138-2012; Lot 09M009;

               5) Maxichlor PEH, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0444-01. Recall #D-                        1139-2012; Lot 09M011;

               6) Maxichlor PEH DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0445-01.  Recall #      D-1140-2012; Lot 09M010;

               7) Maxichlor PSE, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0442-01. Recall # D-         1141-2012; Lots 09F023, 09F024 09F025;

               8) Maxichlor PSE DM, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0443-01. Recall #       D-1142-2012; Lots 09F028, 09F029, 09F030;

               9) Chlorpap, IMMEDIATE-RELEASE TABLET, 100 tablets, NDC 29273-0100-01. Recall # D-1143-                       2012; Lot 09G001

               RECALLING FIRM/MANUFACTURER

               TG United, Inc., Brooksville, FL, by letter on December 17, 2011. Firm Initiated recall is ongoing.

               REASON

               CGMP Deviations: TG United, Inc. is recalling Chlorpap and Maxichlor tablet drug products for blending          problems.

Jan 6      Draft Guidance for Industry:  Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.  This draft guidance updates and clarifies FDA’s policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf?source=govdelivery

Jan 6      5) Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.  This report identifies the FDA’s ‘‘best practices’’ and makes recommendations to streamline the development of guidance documents, reduce the time between issuing draft and final guidance documents, and make it easier to find guidance documents on FDA’s Web site.  Download at: http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM285124.pdf?source=govdelivery 

Jan 4      CDC Awards $339 Million of Tax Payer Money to Health Departments for High-Impact HIV Prevention.  The Centers for Disease Control and Prevention has begun awarding a total of almost $339 million to state and local health departments across the United States to fund HIV prevention activities this year. The awards are for the first year of a five-year funding cycle and represent a new direction for CDC HIV funding designed to achieve a higher level of impact with every federal HIV prevention dollar spent.  CDC will award an additional $20 million to health departments by March 2012 as part of this funding cycle to implement innovative HIV prevention demonstration projects.

Dec 27   Request for Comments: Guidance for Industry on Post-marketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.  FDA is collecting comments on the FDA guidance for industry on ‘‘Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.’’ This guidance document provides recommendations on post-marketing serious adverse event reporting for nonprescription (over-the-counter) human drugs marketed without an approved application. Please submit either electronic or written comments on the collection of information by February 27, 2012.  Obtain the guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171672.pdf?source=govdelivery

Dec 28               Recalls – Class II 

               PRODUCT   FLUOXETINE Capsules USP, 10 mg, 1000-count Capsules per bottle, Rx only, NDC 50111-647-03. Recall # D-1125-2012; Lot: 35201238A, exp 05/2013

               RECALLING FIRM/MANUFACTURER

               Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 30, 2011. 

               Manufacturer: Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.

               REASON

               CGMP Deviations: Firm's laboratory investigation was not performed in accordance with strict adherence       to the "FDA Guidance for Industry Investigating Out-of-Specification Test Results for Pharmaceutical        Production."

               PRODUCT

               Tetracycline Hydrochloride Capsules USP, 500 mg, 1000-count capsules per bottle, Rx only, NDC 0172-               2407-80. Recall # D-1128-2012; Lot # 34002105B, exp 4/2014

               RECALLING FIRM/MANUFACTURER

               Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on November 21, 2011.

               Manufacturer: Barr Laboratories, Inc. (div. of Teva), Forest, VA. Firm initiated recall is ongoing.

               REASON

               Presence of Particulate Matter.

Dec 28   Recalls – Class III

               PRODUCT

               Metformin Hydrochloride Tablets, USP, 1000 mg, 100-count tablets per bottle, Rx only, NDC 65862-010-  01. Recall # D-1126-2012; Lot MTSC10038-A; Exp. Date August 2012

               RECALLING FIRM/MANUFACTURER

               Recalling Firm: Aurolife Pharma LLC, Dayton, NJ, by letter on January 6, 2011.

               Manufacturer: Aurobindo Pharma Ltd., Polepally(v) Jadcherla, India. Firm initiated recall is ongoing.

               REASON

               Labeling: Label Mix-up: Some bottles of Metformin Tablets 1000 mg were mislabeled as 500 count   instead of 100 count.

Dec 22   FDA Announced Today that Triple A Services, Inc., a Chicago–area sandwich manufacturer has                agreed to stop production.  This action was prompted by unsanitary conditions favorable to Listeria                growth and a history of violations.

Dec 22   FDA Sent Warning Letters to the Following Companies for Misrepresenting Their Products:             Dr. Reddy’s Laboratories, Inc., Bridgewater, NJ 08807                - Fondaparinux Sodium Solution                                                                                                                                for subcutaneous injection              Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124  - Colcrys (colchicine) Tablets       

Dec 21   Drug Shortages:  Meda Pharmaceuticals announced shortage of Anadrol-50 (Oxymetholone) Tablets due to active pharmaceutical ingredient constraints.  Meda estimates that Anadrol may be available March 2012.

Dec 21   McNeil Recall of Motrin® IB Tablets and Caplets.  There is no safety concern if consumers continue                taking the product in accordance with its label; however, it is possible there may be a delay in             experiencing relief. This action is not being undertaken on the basis of adverse events.  McNeil is recalling      these products because testing of product samples showed that some caplets may not dissolve as quickly           as intended when nearing their expiration date. Out of an abundance of caution, we are recalling all the             listed products since there is a chance they could experience a similar problem as they approach     expiration.  Call their Consumer Call Center (888-222-6036) with your questions.

Dec 14   Recalls – Drugs Class II

               PRODUCT  Cetrizine Hydrochloride Syrup for oral use only, 1 mg/mL, 120 mL and 480 mL, Rx                         only, NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL). Recall # D-895-2012; approximately                60 lots

               RECALLING FIRM/MANUFACTURER

               Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters on November             11, 2011. Firm initiated recall is ongoing.

               REASON

               Impurities/Degradation Failure; 18 month time point.

               PRODUCT  Glyburide Tablets, USP, 5 mg Rx only, 30 count bottle, NDC 54868-3265-1; 2) 60 count                bottle, NDC 54868-3265-3, 3) 90 count bottle, NDC 54868-3265-4. Recall # D-896-2012; Approximately                30 lots.

               RECALLING FIRM/MANUFACTURER

               Physicians Total Care, Inc., Tulsa, OK, letter dated April 7, 2011. Firm initiated recall is complete.

               REASON

               Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the    package outset.

             PODUCT   Hydroxyzine Pamoate Capsule, USP, 50 mg, 500-count bottle, NDC 0591-0801-05. Recall   # D-875-2012; Lot #: 3087717, Exp 05/2013

               RECALLING FIRM/MANUFACTURER

               Recalling Firm: Watson Laboratories Inc., Corona, CA, by letter on November 7, 2011.

               Manufacturer: Patheon Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.

               REASON

               cGMP Deviations: Some capsules were found to have an additional cap over one-half of the capsule body. 

PRODUCT   1) Albuterol Sulfate Extended-Release Tablets, 4 mg, 100-count tablets per bottle, Rx only; NDC 68774-400-01. Recall # D-884-2012; Lot #: 7549012, Exp 08/12;

2) VoSpire ER (albuterol sulfate) Extended-Release tablets, 4 mg, 6-count tablets per bottle, Rx only; NDC 68774-600-06, Patient Starter Pack. Recall # D-885-2012; Lot # 7549012B, Exp 08/12

RECALLING FIRM/MANUFACTURER

Recalling Firm: DAVA, Inc., Fort Lee, NJ, by letter on August 3, 2011.

Manufacturer: Pliva, Inc., East Hanover, NJ. Firm initiated recall is ongoing.

REASON

Failed USP Dissolution Test Requirements: These lots are being recalled due to a failure on stability test for dissolution at 19-months aging.

Dec 15   Drug Information Update – FDA Drug Safety Communication: Revised Dose Limitation for Zocor (Simvastatin) When Taken With Amiodarone.  The U.S. Food and Drug Administration (FDA) is notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. In June 2011, FDA previously recommended that the dose limitation for simvastatin be decreased from 20 mg to 10 mg, and has now reconsidered that recommendation.  In patients who are taking both simvastatin and amiodarone, the dose of simvastatin should not exceed 20 mg per day. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.

Dec 14   FDA Sent Warning Letters to the Following Companies for Misrepresenting Their Products:

               NeurogesX, Inc., San Mateo, CA 94404                            Qutenza (capsaicin) 8% patch

               Sunovion Pharmaceuticals, Inc., Fort Lee, NJ 07024         Latuda (lurasidone HCl) Tablets

               EUSA Pharma (USA), Inc., Langhorne, PA 19047            ProstaScint Kit (capromab pendetide) 

Dec 7     Recalls – Drugs Class II

PRODUCT   Vitamin D, (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)) , Rx ONLY, a)100 count bottles NDC 0574-0194-01; 15 lots b) 50 count bottle, NDC 0574-0194-50. Recall # D-825-2012; 3 lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: Paddock Laboratories, Inc., Minneapolis, MN, by letters dated September 6, 2011. 

Manufacturer: Strides Arcolab Ltd., Bangalore, India. Firm initiated recall is ongoing.

REASON

Presence of Foreign Substance(s): Paddock Laboratories is recalling Vitamin D - Ergocalciferol Capsules, USP 1.25 mg (50,000 IU) 50 & 100 count capsules because it may contain extraneous foreign matter (glass chip) in product container.          

PRODUCT   SeroQUEL quetiapine fumarate 300 mg tablets, 60 tablets, Rx only, NDC 0310-0274-60.

Recall # D-860-2012; Lot YB0130, exp 1/9/2014

RECALLING FIRM/MANUFACTURER

Recalling Firm: AstraZeneca LP, Wilmington, DE, by letter on November 14, 2011.   
Manufacturer: AstraZeneca Pharmaceuticals, LP, Newark, DE. Firm initiated recall is ongoing.

REASON

Presence of Foreign Substance(s): Recalled due to the potential presence of inert polyvinylchloride (PVC) material in the product

PRODUCT  1) Children's PANADOL Liquid (Acetaminophen), 80 mg, fl. oz., 2 fl. oz. and 4 fl. oz bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1. Recall # D-876-2012;

2) Children's PANADOL Chewable Tablets, (Acetaminophen), 80 mg, 32 ct tablets,

UPC: 3-09711-03140-3. Recall # D-877-2012;

3) Infant's PANADOL (Acetaminophen) Drops, 80 mg per 0.8 mL dropper, fl. oz. bottles, UPC: 3-12843-21496-5. Recall # D-878-2012;

4) PANADOL Cold & Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 16 Caplets and 2 pouch x 50 packets/carton, UPC 3-09711-05005-3. Recall # D-879-2012;

5) Maximum Strength CONTAC Cold + Flu, (Acetaminophen 500mg, Chlorpheniramine Maleate 2mg and Phenylephrine HCl 5mg), 30 packets, 2 caplets per packet. UPC: 3-09711-232405-7. Recall # D-880-2012

6) Mejoralito, Children's Liquid (Acetaminophen), 2 fl oz bottles, Code: UPC: 0-53100-44310-9. Recall # D-881-2012;

7) Mejoralito, Children's Chewable Tablets (Acetaminophen), 80mg, 32 count bottles, UPC: 0-53100-44210-2. Recall # D-882-2012;

8) Women's Extra Strength PANADOL, Menstrual Relief, Multi-Symptom Caplets, (Acetaminophen 500mg, Pamabrom 25mg), 24 count bottles, UPC: 3-112843-21493-4; UPC: 3-12843-21494-1, UPC 3-09711-21491-2. Recall # D-883-2012

CODE:  Numerous lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: GlaxoSmithKline Inc., Zebulon, NC, by letter on/about October 6, 2011. 

Manufacturers: GlaxoSmithKline Panama S.A., Panama, Panama,

Manufacturer: GlaxoSmithKline Costa Rica, S.A., San Jose, Costa Rica. Firm initiated recall is ongoing.

REASON

CGMP Deviations; Some of the analytical process validation activities did not contain primary data. 

PRODUCT   Leflunomide Tablets, 10 mg, Rx Only, 30-count Bottle, NDC 0093-0173-56. Recall # D-872-2012; Lot # 30209292A, Exp 11/2011

RECALLING FIRM/MANUFACTURER

Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on October 31, 2011. Firm initiated recall is ongoing.

REASON

Impurities/Degradation Products: One lot of this product does not meet impurity specifications.

Dec 7     Recalls:  Drugs – Class III 

PRODUCT   Neomycin Sulfate Tablets, USP, 500 mg, Rx Only, Unit Dose 100 Tablets (10 Strips of 10 Tablets per carton), NDC 39822-0310-5. Recall # D-854-2012; Lot: FGX, Exp. 02/2012

RECALLING FIRM/MANUFACTURER

Recalling Firm: X-gen Pharmaceuticals Inc., Horseheads, NY, by letter and follow up telephone and e-mail on September 26, 2011.

Manufacturer: Patheon Inc. Whitby Operations, Whitby Ontario, Canada. Firm initiated recall is ongoing.

REASON

Discoloration: Some tablets were reported discolored resulting from improper sealing of the blister packaging.

Dec 7     U.S. Marshals Seize Products Containing Ephedrine.      At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements.  The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market.  Judge Gary A. Feess of the Central District of California issued a warrant for the seizure of more than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing the ephedrine alkaloids. 

Nov 30   Ben Venue Laboratories – Voluntary Shutdown.  Ben Venue Laboratories, Inc. (“BVL”) announced the voluntary shutdown of manufacturing and distribution at its site in Bedford, Ohio due to significant manufacturing and quality concerns. BVL’s decision to shut down is a result of BVL’s findings. The company notified the U.S. Food and Drug Administration as soon as they made the decision to shut down. Manufacturing and distribution of all products from this site are currently on hold; however, products already in distribution will remain on the market until further analysis is complete.  FDA is working with BVL to address the impact this shutdown may have on the availability of certain drugs. FDA has been and will continue to work with BVL in prioritizing the quality issues to be addressed in order to help bring the company back to production as soon as possible.

Nov 30   FDA approves first generic version of cholesterol-lowering drug Lipitor.   The U.S. Food and Drug Administration today approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).  Ranbaxy Laboratories Ltd. has gained approval to make generic atorvastatin calcium tablets in 10 milligram, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories in New Brunswick, N.J.  People who have high blood cholesterol levels have a greater chance of getting heart disease. By itself, the condition usually has no signs or symptoms. Thus, many people do not know that their cholesterol levels are too high.  “This medication is widely used by people who must manage their high cholesterol over time, so it is important to have affordable treatment options,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We are working very hard to get generic drugs to people as soon as the law will allow.”

Nov 23   New Guidance:  Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).   This guidance can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf

Nov 22   CDC’s Annual Get Smart About Antibiotics Week.  Antibiotic resistance is not a scare tactic or a doomsday scenario; it’s a real and present danger confronting hospitals and healthcare facilities throughout the world. From 2006 to 2008, rates of resistance to the antibiotic imipenem among bacteria Acinetobacter bacteria doubled.  And that’s just one example.

To solve this problem, many would suggest the creation of new drugs. Yet, only two new antibiotics have been approved by the FDA since 2008, and the pipeline of new drugs is nearly dry. Even if a company was to begin developing a new drug today and have no development issues, the drug would not reach the market until 2020.  More info at:  http://www.cdc.gov/getsmart/healthcare/getSmartWeek.html 

Nov 18   FDA Commissioner Announces Avastin Decision.  FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.  Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).  Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines. 

Nov 18   FDA has Approved asparaginase Erwinia chrysanthemi (Erwinaze Injection) as a component of a multi-agent chemotherapeutic regimen for treatment of leukemia.  The approval was based on one clinical study in 58 patients with ALL who were unable to continue receiving pegaspargase or asparaginase derived from E. coli due to allergic reactions. The major efficacy outcome was attainment of sustained serum asparaginase activity levels of 0.1 IU/mL or higher, which is known to result in depletion of asparagine to levels that predict efficacy. Among 48 patients with available samples, all patients achieved this threshold trough level of asparaginase activity.  Safety was evaluated in 58 patients treated on the clinical study and in 574 patients treated on the Erwinaze Master Treatment Protocol (EMTP), an expanded access program. The most serious adverse reactions included allergic reactions (including anaphylaxis), pancreatitis, abnormal transaminases, coagulopathies, hemorrhage, nausea, vomiting and hyperglycemia. Common adverse reactions were similar in severity and incidence to those attributable to E. coli-derived asparaginase.  More information at:  http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm280543.htm

Nov 18   Tool Developed for Small Business to Find and Compare Health Insurance Plans.  A greatly expanded website to give small business owners an unprecedented detailed review of their health insurance plan choices was announced today by the U.S. Department of Health and Human Services. The tool is located on www.HealthCare.gov, which was created under requirements contained in the Affordable Care Act, the new health care law of 2010.  The website is the first of its kind to bring information and links to health insurance plans to one place, and to make it easy for consumers to learn about and compare their insurance options.  Insurance product choices for a given ZIP code are sorted by out-of-pocket limits, average cost per enrollee, or other factors.

Nov 18   FDA/PhUSE Annual Computational Science Symposium.  The foundation of the product development process is the ability to efficiently acquire, store, and analyze the data and documents to make informed and timely decisions. The focus of the 3rd Annual Computational Science Symposium is to continue the work initiated at the previous annual meetings by bringing FDA, industry, and academia together to provide an update on current initiatives ongoing within the FDA and establish collaborative working groups to address current challenges related to the access and review of data to support product development. The final working groups are listed below.
               Working Group 1: Data Validation and Quality Assessment
               Working Group 2: Reducing Risk within the Inspection Site Selection Process
               Working Group 3: Challenges of Integrating and Converting  Data across Studies
               Working Group 4: Standards Implementation Issues with the CDISC Data Models
               Working Group 5: Development of Standard Scripts for Analysis and Programming
               Working Group 6: Non-clinical road-map and impacts on Implementation                      Registration is now open at: http://www.phuse.eu/css

Nov 18   Warning Letters: 

               Altaire Pharmaceuticals, Inc. of Aquebogue, NY.  On November 16, 2011, FDA sent a warning letter because the company was cited for manufacturing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, the unapproved drugs named were:  Freshkote® Sterile Ophthalmic Solution (containing 2% polyvinyl pyrrolidone, 0.9% polyvinyl alcohol, and 1.8% polyvinyl alcohol) as well as Fluorescein Injection 250 mg/ml (Fluorescein Lite 25%), 100 mg/ml (Fluorescein Lite 10%), 250 mg/ml (Fluorescein Sodium Injection 25%), and 100 mg/ml (Fluorescein Sodium Injection 10%).

CJ Labs, Inc. of Miami, FL 33186  On November 16, 2011, FDA sent a warning letter because at the conclusion of June 24 inspection, the company was issued a Form FDA 483, List of Inspectional Observations, which listed a number of the violations that caused their dietary supplement products, Milk Thistle and L-Carnitine, to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.  In addition, based on their review of the company’s product labels, FDA determined that the products, Nutra Stress Tablets, Tri-flex Capsules, Noni Juice, Arthritis Formula Capsules, and Prostaguard Capsules, are promoted for conditions that cause them to be drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on their labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  Furthermore, the company’s products, Cardispan Levocarnitina and Collagen Cream With Dribble of the Snail, are cosmetics within the meaning of section 201(i) of the Act [21 U.S.C. 321(i)] because they are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. As such, FDA has determined that these cosmetic products are misbranded within the meaning of section 602(a) of the Act [21 U.S.C. § 362(a)] because the ingredients in each product are not listed on the label in accordance with 21 CFR 701.3. 

Focus Laboratories, Inc. of North Little Rock, AR 72113-6656.  On November 16, 2011, FDA sent a warning letter because the company was cited for manufacturing an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically the unapproved drug named was Freshkote® Sterile Ophthalmic Solution, containing 2% polyvinyl pyrrolidone, 0.9% polyvinyl alcohol, and 1.8% polyvinyl alcohol.

Hub Pharmaceuticals, LLC, of Rancho Cucamonga, CA 91730.  On November 16, 2011, FDA sent a warning letter because the company was cited for manufacturing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, the unapproved drugs named were:  Fluorescein Injection 250 mg/ml (Fluorescein Injection U.S.P. Lite 25%),  100 mg/ml (Fluorescein Injection U.S.P. Lite 10%),  250 mg/ml (Fluorescein Injection U.S.P. Dark 25%),  and 100 mg/ml (Fluorescein Injection U.S.P. Dark 10%).

               WellnessOne World, LLC, Ramsey, Minnesota.  On November 16, FDA sent a warning letter because during an inspection of their facility in June, inspectors found unapproved new drugs and Dietary Supplement cGMP violations.  Read the letter at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm280713.htm   

Mylan Laboratories, Inc., Caguas, Puerto Rico 00901.  On October 13, 2011, FDA sent a warning letter because during an inspection from January 24 to February 24, 2011, their inspectors identified significant violations of current Good Manufacturing Practice Regulations for finished pharmaceuticals including but not limited to 1. Insufficient laboratory determination of conformance to specifications prior to release of drug product, 2.  No rationale for not completing content uniformity testing, 3. No justification to invalidate OOS result of 19.2% of label claim for Loperamide HCl.

               WellnessOne World, LLC, Ramsey, Minnesota.  On November 16, FDA sent a warning letter because during an inspection of their facility in June, inspectors found unapproved new drugs and Dietary Supplement cGMP violations.  Read the letter at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm280713.htm   

Nov 9     Drug Information Update - FDA Drug Safety Communication: Review update of Trilipix (fenofibric acid) and the ACCORD Lipid trial.  The U.S. Food and Drug Administration (FDA) is informing the public that the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. This is based on data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial, which evaluated the efficacy and safety of fenofibrate plus simvastatin combination therapy versus simvastatin alone in patients with type 2 diabetes mellitus (see Data Summary at link:  http://www.fda.gov/Drugs/DrugSafety/ucm278837.htm    FDA reviewed this trial as part of its ongoing investigation of the safety and efficacy of Trilipix.  In the ACCORD Lipid trial, there was no significant difference in the risk of experiencing a major adverse cardiac event between the group treated with fenofibrate plus simvastatin compared with simvastatin alone. In addition, a subgroup analysis showed that relative to treatment in men, there was an increase in the risk for major adverse cardiac events in women receiving the combination therapy versus simvastatin alone. The clinical significance of this subgroup finding is unclear, as this finding was not observed in a separate large randomized controlled clinical trial of fenofibrate versus placebo. 

Nov 8     Drug Shortage – Tetracycline Capsules   Both Teva Pharmaceuticals and Watson Pharmaceuticals cite manufacturing delays as the reason for the shortage.  In addition they stated, “All tetracycline capsules are temporarily unavailable and the company cannot estimate a release date.” 

Nov 7     Recalls – Drugs –  II 

PRODUCT    Over the past two months over 500 drug products were recalled including, but not limited to, Acetaminophen, Albuterol, Amoxicillin Aspirin, Butalbital/APAP/ Caffeine, Conjugated Estrogens, Glimepiride, Glyburide, Guaifenesin Hydrochlorothiazide, Hydrocodone/Acetaminophen, Ibuprofen, Tamoxifen citrate, Tetracycline HCl, Theophylline anhydrous, Thyroid, and Triamterene/hydrochlorothiazide, Warfarin, Verapamil, and Zolpidem Tartrate                                                RECALLING FIRM/MANUFACTURER                                                                                       Aidapak Services, LLC, Vancouver, WA, by letters on May 27, 2011, May 28, 2011 and May 31, 2011 and by press release on June 1, 2011. Firm initiated recall is ongoing.

REASON

Penicillin Cross Contamination; There is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.

Nov 7     FDA approves Erbitux to treat late-stage head and neck cancer   Combined with chemotherapy, Erbitux extended the lives of those receiving the treatment combination compared with those receiving chemotherapy alone. Erbitux already is FDA-approved for certain types of colon cancer, and has been approved since 2006 for treatment of non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).  According to the National Cancer Institute, head and neck cancers account for 3 percent to 5 percent of all cancers in the United States. These cancers typically develop in the nose, throat or mouth and they are more common in men and in people older than 50. The safety and effectiveness of Erbitux for this indication is based on the results of a multi-center clinical study conducted outside the United States involving 442 patients with metastatic or recurrent head and neck cancer. The study used a non-U.S. approved version of cetuximab, rather than the U.S.-approved formulation.  Participants had inoperable or widespread disease and had not received prior chemotherapy. Half were selected to receive either the combination of cetuximab with chemotherapy (cisplatin or carboplatin and 5-fluorouracil) or chemotherapy (cisplatin or carboplatin and 5-fluorouracil) only. Patients receiving the cetuximab with chemotherapy combination lived, on average, 10.1 months compared with 7.4 months for those receiving chemotherapy only. The most common side effects reported in patients receiving cetuximab were rash, itching (pruritus), nail changes, headache, diarrhea, and respiratory, skin, and mouth infections. Erbitux also can cause low serum magnesium, potassium, and calcium. Erbitux has been associated with serious and potentially life-threatening infusion reactions and heart attack. Patients taking Erbitux should limit their exposure to the sun.  Erbitux is co-marketed by New York City-based Bristol-Myers Squibb and Eli Lilly and Company based in Indianapolis, Indiana.       

Nov 4     FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm.  The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation).  Atrial fibrillation occurs in more than 2 million Americans and is one of the most common types of abnormal heart rhythm. In atrial fibrillation, the beating of the heart’s two upper heart chambers (atria) is irregular and poorly coordinated. This leads to blood pooling in these chambers, resulting in blood clots. Non-valvular atrial fibrillation refers to atrial fibrillation in patients who do not have significant problems in their heart valves.  Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke.  A stroke occurs if the flow of blood to a portion of the brain is blocked. If brain cells die or are damaged because of a stroke, symptoms occur in the parts of the body that these brain cells control. Stroke symptoms include sudden weakness; paralysis or numbness of the face, arms, or legs; trouble speaking or understandin, g speech; and trouble seeing.  The safety and efficacy of Xarelto were evaluated in a clinical trial with more than 14,000 patients comparing Xarelto with the anti-clotting drug warfarin. In the trial, Xarelto was similar to warfarin in its ability to prevent stroke.  For people taking the drug for atrial fibrillation, Xarelto should be taken one time a day with the evening meal so that it will be completely absorbed.  Xarelto is marketed in the United States by Titusville, N.J.- based Janssen Pharmaceuticals Inc.

Nov 3     FDA Says It Approved 35 innovative new drugs in fiscal year 2011.   This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years.   Read more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278383.htm

Nov 2     Recalls – Class II

PRODUCT    Twenty-six products including Fentanyl/Riouvacaube Epidural Bag, Hydromorphone PCA Syringe, Morphine 1mg/ml PCA 100ml Intravia Bag, and Vancomycin IV Bag.                                                  RECALLING FIRM/MANUFACTURER                                                                                       Advanced Specialty Pharmacy LLC, Birmingham AL by letter on March 24, 2011.  Firm initiated recall is ongoing. 

REASON

Lack of Assurance of Sterility - Penicillin Cross Contamination; There is potential for beta-lactam cross contamination of non-penicillin drug products repackaged in the same facility.

Oct 31    HHS provided more than $1.7 billion to states to help low-income households with energy costs.  Today, HHS announced the release of more than $1.7 billion to help low income citizens with their heating and home energy costs. These funds will go to states, tribes and territories under the Low Income Home Energy Assistance Program (LIHEAP) block grant.  A complete list of funds available to states today is below: http://www.acf.hhs.gov/news/press/2011/2012CR-LIHEAP_1stQTR.html.

Oct 31    Notification to Pharmaceutical Companies: Change in Timeframe for Cetero Studies Requiring Reevaluation.  The FDA is notifying pharmaceutical companies of a change in timeframe for bioanalytical studies conducted by Cetero Research, Houston (Cetero) that may need to be repeated or confirmed.  The updated timeframe for studies with data integrity concerns is April 1, 2005 to August 31, 2009.  Please find additional information at:  http://www.fda.gov/Drugs/DrugSafety/ucm265559.htm

Oct 26    Recalls

PRODUCT   Twenty-seven drug products including Tylenol brand, Benadryl brand. Sudafed PE brand and Sinutab brand                                                                                                                                                RECALLING FIRM/MANUFACTURER                                                                                             McNeil Consumer Healthcare, Div of McNeil, PPC, Inc., Fort Washington, PA, by letters on January 14, 2011. Firm initiated recall is ongoing.

REASON

CGMP Deviations: Review of production records found instances where equipment cleaning procedures were insufficient or that cleaning was not adequately documented.

Oct 25    FDA is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.  Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2011-10-19/pdf/2011-27037.pdf

Oct 25    Guidance for Industry: ‘‘Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ This guidance is intended to assist applicants and reviewers in drafting the ‘‘Warnings and Precautions, Contraindications, and Boxed Warning’’ sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.  Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2011-10-12/pdf/2011-26297.pdf     Guidance Document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075096.pdf

Oct 25    The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.  Schizophrenia is a chronic, severe, and disabling brain disorder. About 1 percent of Americans have this illness. Symptoms people with schizophrenia have include: hearing voices, believing other people are reading their minds or controlling thoughts, and being suspicious or withdrawn.  Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

Oct 21    Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.  Lennox-Gastaut syndrome usually begins before 4 years of age, and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In 30 to 35 percent of patients, no cause can be found.

Oct 19    Insight Pharmaceuticals Issues A Voluntary Nationwide Recall Of "Nostrilla Nasal Decongestant" Due To Bacterial Contamination.  Insight Pharmaceuticals, LLC of Langhorne, Pa., is recalling one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.  Learn more at:  http://www.fda.gov/Safety/Recalls/ucm276721.htm

Oct 17    FDA granted accelerated approval to deferiprone (Ferriprox Tablets, ApoPharma, Inc.).  Deferiprone is an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.  More Information: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm275836.htm

Oct 15   Guidance for Industry – Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf

Oct 11   FDA Organizational Changes.  A few weeks ago, FDA announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP). Please find information about this reorganization at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm271501.htm

Oct 11    Guidance for Industry: Time and Extent Application for Nonprescription Drug Products  This guidance document is intended to explain what information an applicant should submit to the FDA to request that a drug product be included in the over-the­ counter (OTC) drug monograph system and to describe the process for submitting that information.  Please find this guidance document at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078902.pdf

Oct 11    Guidance for Industry: E2F Development Safety Update Report.  The development safety update report (DSUR) proposed in this guidance is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. U.S. and European Union (EU) regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the U.S. investigational new drug application (IND) annual report and the EU annual safety report, respectively, and can therefore take the place of these existing reports. This guidance defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.  Please find this guidance document at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073109.pdf

Oct 6     Daniel Fabricant:  Supplement Safety is Priority.  Daniel Fabricant, an expert on drugs made from natural substances, came to FDA in February to head the agency’s Division of Dietary Supplements. Fabricant says he’ll use his knowledge of the supplement industry to improve manufacturing practices---part of his overall effort to ensure dietary supplements are safe for U.S. consumers.  To learn more about Fabricant and what he’ll be doing at FDA, visit, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm274599.htm

Oct 6      More people using free preventive benefits provided by Affordable Care Act.  Some of the free preventive services available to people with Medicare include:                                                                                       Mammograms and cervical cancer screenings                                                                                             Annual Wellness Visit                                                                                                                                 Cholesterol and other cardiovascular screenings                                                                                         Colorectal and prostate cancer screenings                                                                                 To learn more, go to:  http://www.hhs.gov/news/press/2011pres/10/20111006b.html

Oct 4     Changes in Bevacizumab Labeling.  Changes in bevacizumab (Avastin, Genentech, Inc.) package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event.  September 30, 2011 More Information: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm274394.htm

Oct 4      FDA approves gel to stop blood flow during blood vessel surgery.  The U.S. Food and Drug Administration has approved LeGoo, a gel that allows surgeons to temporarily stop blood flow during surgery so that they can join blood vessels without clamps or elastic loops.  LeGoo is a temperature sensitive gel that is liquid at room temperature and solid at higher temperatures. When injected into a blood vessel, LeGoo forms a gel plug that molds to the shape of the blood vessel and stops blood flow for up to 15 minutes.  Details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm274372.htm

Sep 26    Guidance for Industry:  User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.       Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079298.pdf

Sep 23   Warning Letters

  Sichuan Pharmaceutical Co., Ltd of Pengzhou, Sichuan, China.  On September 9, 2011, FDA sent a warning letter because the company had failed to take appropriate procedures to prevent cross contamination during manufacture of active pharmaceutical ingredients (APIs).  Also they were cited for not conducting adequate decontamination, renovation and activation of the facility.  In addition the firm had not registered or listed every API in commercial distribution in the USA with the FDA. 

Sep 19    FDA Issues Revised Guidance on Marketed Unapproved Drugs.  FDA today announced a revision to its 2006 guidance titled “Marketed Unapproved Drugs-- Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs” (CPG 440.100).  You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf

Sep 16    Guidance for Industry – Self-Selection Studies for Non-prescription Drug Products.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf

Aug  9 HHS awards Affordable Care Act funds to expand access to health care    Heath and Human Services announced today awards of $28.8 million to 67 community health center programs across the country. These funds, made available by the Affordable Care Act, will help to establish new health service delivery sites to care for an additional 286,000 patients. Community health centers work to improve the health of the nation's underserved communities and vulnerable populations by ensuring access to comprehensive, culturally competent, quality primary health care services.  More at:  http://www.hhs.gov/news/press/2011pres/08/20110809a.html

Aug  9 Enforcement Reports

             1.  Recalling Firm: Novartis Pharmaceuticals Corp., Suffern, NY, by letters dated July 1, 2011.                                 Manufacturer: Patheon Inc., Toronto Region Operations, Mississauga Ontario, Canada. Firm initiated                    recall is ongoing.                                                                                                                                                         Product:  Fanapt (iloperidone), 12 mg, 60-count bottle, Rx only; NDC 43068-112-02. Recall # D-724-                   2011                                                                                                                                                                            Lot numbers: V0230A001, V0230A001S, and V0230A001S2, Exp 05/31/12                                                          Reason:   Failed Tablet Hardness: During stability testing, a low out of specification (OOS) result for                    mean hardness was obtained; this decreased hardness could result in tablet friability leading to tablet                    breakage.             

             2.   Recalling Firm: Pfizer Us Pharmaceutical Group, New York, NY by letters on June 30, 2011 and on                    July 8, 2011.                                                                                                                                                                Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.                                    Product:  Alprazolam XR, extended-release tablets, 2 mg, 60-count bottle, Rx only, NDC 59762-0066-1.                Recall # D-726-2011; Lot Numbers: C090023, Exp 11/11                                                                                        Reason:  Failed USP Dissolution Test Requirements: The 24-month stability testing yielded an out-of-                    specification result for dissolution.

             3.   Recalling Firm: HS Pharmaceuticals, LLC, Greenville, SC, by letter on July 6, 2011.                                            Manufacturer: Shertech Laboratories, LLC, Duncan, SC. Firm initiated recall is ongoing.                                    Product:  Bensal HP (benzoic acid 60 mg and salicylic acid 30 mg per gram) Topical Ointment, a)15                    gram tube, NDC 63801-107-09, UPC 3 63801 10709 6; b) 30 gram tube, NDC 63801-107-01, UPC 3                    63801 10701-0; Rx only. Recall # D-730-201; Lot number: 10001, Exp 10/13                                                       Reason:  CGMP Deviations: HS Pharma initiated this recall after investigating reported product failures                    and labeling deficiencies with their contract manufacturer. HS Pharma's name is currently absent from                    the outer carton and the firm has been unsuccessful in obtaining manufacturing documents pertaining to                    the production of Bensal HP. Laboratory analysis suggests that the product formulation may have been                    changed in a manner that causes the product not to meet specifications.

Aug  9    Medicare Prescription Drug Premiums Will Not Increase, More Seniors Receiving Free Preventive Care, Discounts in Donut Hole.  Medicare average prescription drug premiums will not increase in 2012. The announcement from the U.S. Department of Health and Human Services (HHS) comes as more people with Medicare are receiving discounts on prescription drug costs and no-cost preventive services. New data indicates that 17 million people with Medicare have received free preventive services this year while 900,000 Medicare beneficiaries who hit the prescription drug donut hole have received a 50 percent discount on their prescription drugs.  According to HHS under the Affordable Care Act, people with Original Medicare can receive recommended preventive benefits and a new annual wellness visit without paying an additional penny out of pocket.  In addition, the Affordable Care Act is closing the prescription drug donut hole by providing increasing discounts on covered drugs in the donut hole.  In 2011, the number of people with Medicare benefiting from these improvements is growing.  Read more at:  http://www.hhs.gov/news/press/2011pres/08/20110804a.html

Aug  4    Vasopressin Injection USP, Multiple Dose Vials: Recall – Subpotency.   American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This product recall was initiated by American Regent, Inc. because some vials may not maintain potency throughout their shelf-life. Potential adverse events after administration of solutions that are below potency limits may include reduced effectiveness. See the company Press Release for a listing of affected lot numbers. The products were distributed to wholesalers and distributors nationwide.  Vasopressin Injection, USP is indicated for prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus.

Aug  3    FDA Approves First Scorpion Sting Antidote.  “Once stung, twice shy” are words to live by in the Southwestern United States, where about 11,000 people a year are stung by scorpions in Arizona alone.  Though rarely life threatening, scorpion stings can be extremely painful, causing numbness and burning at the wound site. And there’s been little a victim could do to ease the pain. Until now.  The Food and Drug Administration has just approved the first treatment specifically for the sting of the Centruroides scorpion, the most common type in the United States.  The new biologic treatment—called Anascorp—was given a priority review because adequate treatment did not exist in the United States, says Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.  “This product provides a new treatment for children and adults and is designed specifically for scorpion stings,” Midthun says. “Scorpion stings can be life-threatening, especially in infants and children.”  Severe stings can cause loss of muscle control and difficulty breathing, requiring heavy sedation and intensive care in a hospital. Most often, it’s small children who experience severe reactions, but adults can be affected, too, says Keith Boesen, managing director of the Arizona Poison and Drug Information Center (APDIC).  Anascorp was developed in Mexico and has been used there for many years, according to University of Arizona researchers who led the U.S. study of the drug. It’s made from the plasma of horses immunized with scorpion venom and vaccinated against viruses that could infect humans. Researchers began studying the drug in Arizona hospitals in 2004 and found it to be highly effective against the sting of the bark scorpion (also called the Arizona bark scorpion)—the most poisonous scorpion in the U.S.

Aug  3    CDER Public Workshop:  Approach to Addressing Drug Shortage.  FDA is announcing a public workshop regarding the approach of the CDER to addressing drug shortages. This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help in developing topics for further discussion with industry and professional societies, and other stakeholders and may help the Agency to better address drug shortage issues.   The public workshop will be held on September 26, 2011, from 8:30 a.m. to 4:30 p.m. Please find information about the meeting and registration at:  http://www.gpo.gov/fdsys/pkg/FR-2011-07-28/pdf/2011-19031.pdf

Aug  3    FDA Drug Safety Podcast: Long-term, high dosage use of Diflucan during pregnancy may lead to rare birth defects.  On August 3, 2011 the Food and Drug Administration issued a Drug Safety Communication that explains how long-term, high dosage use of diflucan during pregnancy may be associated with rare birth defects.  Fluconazole (floo kon' na zole), marketed under the name Diflucan, is an antifungal medication used to treat infections in the skin, the mucous membranes of the mouth, the respiratory tract, or the vagina.  Using Diflucan in doses from 400 to 800 milligrams, for several weeks or more, may be associated with a rare and distinct set of birth defects in infants. Usually, birth defects occurred when mothers were treated with the drug during the first trimester of pregnancy. The risk does not appear to be associated with a single, low dose of Diflucan at 150 milligrams, used to treat vaginal fungus infections.  Read more at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm267095.htm

Aug  3    Resolved Drug Shortage – Xeloda 500 mg Tablets.  Genentech announced that they have released new production of this product.

Aug  3    FDA, International Counterparts Report Progress on Drug Inspection Collaboration.    FDA, together with its European and Australian counterparts, today released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.   The report on the Good Clinical Practice (GCP) initiative details the success of information-sharing and collaboration on inspections relating to clinical trials. The report on the Active Pharmaceutical Ingredients initiative details the success of information-sharing among the FDA, Australia’s Therapeutic Goods Administration and for Europe, the EMA, France, Germany, Ireland, Italy, the United Kingdom and European Directorate for the Quality of Medicines & Healthcare (EDQM).  Please find additional information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm266305.htm

Aug  2    Drug Shortage:  Anadrol-50 Tablets (Oxymetholone Tablets).  Meda Pharmaceuticals, Inc., announced that this shortage is due to active pharmaceutical ingredient (API) constraints.  Meda cannot estimate a release date for additional supplies of Anadrol-50 Tablets.

June 24 Guidance for Industry - Q4B Evaluation and Recommendation of Pharmaceutical Texts for Use in the ICH Regions: Annex 7 (R2) Dissolution Test Chapters.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM085366.pdf

June 21  Drug Shortage – Levorphanol 2 mg Tablets.  Roxane Laboratories has indefinitely discontinued this product.

June 21  Recalled Products:                                                                                                                                            1) Ropinirole Hydrochloride Tablets in 3 mg, 4 mg, and 5 mg strengths recalled by CorePharma, Middlesex, NJ, due to incorrect (obsolete) version of package outsert.                                                          2) Methylprednisolone Tablets in 4 and 8 mg strengths recalled by Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD because products may contain soft or low weight tablets.

June 20  Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of Risperdal Tablets and One Lot of Risperidone Tablets.  Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).  TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. In January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.  The RISPERDAL® lot - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.

RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.  RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania.  RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children ages 5-16.

June 20 FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings.  FDA's Center for Drug Evaluation and Research (CDER) recently learned that there have been recent instances when clouding and flavoring agents, which have been used outside the U.S. in certain food manufacturing processes, contain undeclared phthalate plasticizers, specifically diethylhexyl-phthalate (DEHP) and diisononyl-phthalate (DINP).  CDER is not aware at this time of any intentional phthalate substitution, in part or whole, in finished pharmaceuticals or pharmaceutical ingredients used in the U.S. market. Nonetheless, significant overlap of global food and pharmaceutical ingredient supply chains raises the potential for adulterated food ingredients to enter the U.S. pharmaceutical supply chain.  CDER advises manufacturers of drug products and suppliers of pharmaceutical ingredients, both in the U.S. and abroad, to be aware of the potential substitution of phthalate plasticizers for vegetable oils in clouding and flavoring agents.  Manufacturers using emulsions containing vegetable oils should exercise caution to prevent the use of ingredients that might be intentionally adulterated with phthalates.  Please find CDER’s recommendations to pharmaceutical manufacturers and compounding pharmacies at the following webpage: http://www.fda.gov/Drugs/DrugSafety/ucm259844.htm 

June 15  FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer.  The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.  More information at:  http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm

June 15  Guidance for Industry:  Enforcement Policy – OTC Sunscreen Drug Products Marketed Without and Approved Application.  OTC sunscreens are not yet the subject of an effective final monograph, ; however, OTC sunscreens marketed without approved applications and containing specified active ingredients in section II of this guidance are subject to a final rule issued in 2011 that establishes labeling and testing requirements.  To download the guidance, go to:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf           

June 14  Guidance for Industry and Investigators:  Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM257976.pdf

June 13  FDA Approves Potiga to Treat Seizures in Adults.  Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults. Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.  The most common adverse reactions reported by patients taking Potiga in clinical trials included: dizziness, fatigue, confusion, spinning sensation (vertigo), tremor, problems with coordination, double vision, problems paying attention, memory impairment, lack of strength, and double-vision. Potiga can cause urinary retention, generally within the first six months of treatment, although it can also occur later. Because of the risk of urinary retention, urologic symptoms, such as the inability to start to urinate, weak urine stream, or pain with urination, should be carefully monitored. Urinary retention is a unique side effect among the medications used to treat seizures.  Potiga may cause neuro-psychiatric symptoms, including confusion, hallucinations, and psychotic symptoms. When Potiga is discontinued, these symptoms usually resolve within seven days. Like other antiepileptic drugs, Potiga may cause suicidal thoughts or actions in a very small number of people. Patients should contact their health care professional right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood. 

June 10  FDA Approves Redesigned Labels for Some Merck Drugs.  The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.  Drugs affected by the revisions include: Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258725.htm

June 9    HHS toolkit of public health emergency text messages now available.  A new toolkit of prepared cell phone text messages advising people how to protect their health after a disaster is available now through the U.S. Department of Health and Human Services. These messages support state and local emergency managers in disaster response and are available online at http://emergency.cdc.gov/disasters/psa.

June 9    Draft Guidance for Industry:  Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.  This document is being distributed for comment purposes only.  Read it at:  http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

June 9    FDA Works to Lessen Drug Shortage Impact.  Last year, the number of drug shortages in the U.S. reached a record high, and the medicine scarcities have continued at a rapid pace in 2011. The shortages include cancer drugs, anesthetics used in surgery, and "sterile injectables"--medicines given by injection or intravenously. There have also been shortages of medicines that Americans take by mouth each day.  The Food and Drug Administration is doing what it can to prevent and lessen the severity of the shortages, so patients can continue to receive the medicines they need. To find out what to do if your medicine is in short supply, visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm258152.htm.  

June 9 Guidance for Industry: Citizen Petitions and Petitions for Stay of Action subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079353.pdf

June 8    FDA Recommends Limiting use of 80 mg Simvastatin.  The Food and Drug Administration is recommending that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury.  FDA says this dose should only be used by patients who have been taking it for 12 months or longer without ill effect.  The overall goal is to get doctors to not start patients on 80 mg of simvastatin, if health care professionals find that patients now taking 40 mg of simvastatin aren’t meeting their LDL cholesterol goal, FDA is advising them to choose a different statin rather than raising the simvastatin dose to 80 mg, says Amy Egan, M.D., deputy director for safety in the FDA division.  Read more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257884.htm

June 2    Thermogram No Substitute for Mammogram.  Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.  Despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis.  The Food and Drug Administration (FDA) says mammography— an X-ray of the breast—is still the most effective way of detecting breast cancer in its earliest, most treatable stages.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257499.htm

Aug  2    Drug Shortage:  Anadrol-50 Tablets (Oxymetholone Tablets).  Meda Pharmaceuticals, Inc., announced that this shortage is due to active pharmaceutical ingredient (API) constraints.  Meda cannot estimate a release date for additional supplies of Anadrol-50 Tablets.

Jul 29     The USDA’s Food Safety and Inspection Service (FSIS) Is Issuing A Public Health Alert For Frozen or Fresh Ground Turkey Products.  This public health alert was initiated after continuous medical reports, ongoing investigations and testing conducted by various departments of health across the nation determined there is an association between consumption of ground turkey products and an estimated 77 illnesses reported in 26 states.  FSIS reminds consumers of the critical importance of following package cooking instructions for frozen or fresh ground turkey products and general food safety guidelines when handling and preparing any raw meat or poultry. In particular, while cooking instructions may give a specific number of minutes of cooking for each side of the patty in order to attain 165 °F internal temperature, consumers should be aware that actual time may vary depending on the cooking method (broiling, frying, or grilling) and the temperature of the product (chilled versus frozen) so it is important that the final temperature of 165 °F must be reached for safety. Please do not rely on the cooking time for each side of the patty, but use a food thermometer.  Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

Jul 29    HHS Awards 71.3 Million To Strengthen Nursing Workforce   HHS announced today $71.3 million in grants to expand nursing education, training and diversity.  Nursing workforce development programs, reauthorized by the Affordable Care Act and administered by HHS’ Health Resources and Services Administration, are the primary source of federal funding for nursing education and workforce development.  These programs bolster nursing education at all levels, from entry-level preparation through the development of advanced practice nurses.  They also prepare faculty to teach the nation’s future nursing workforce. The HHS Secretary was quoted as saying, “These awards reflect the critical role of nurses in our healthcare system, and our ongoing commitment to attract and retain highly-skilled nurses in the profession”.  Awards include:

Nurse Education, Practice, Quality and Retention ($10.9 million – 33 awards)                                                     Nursing Workforce Diversity ($3.6 million – 11 awards)                                                                           Nurse Faculty Loan Program ($23.4 million – 109 awards)                                                                        Advanced Nursing Education Program ($16.1 million – 55 awards)                                                          Advanced Education Nursing Traineeships ($16 million – 349 awards)                                                    Nurse Anesthetist Traineeships ($1.3 million – 76 awards)

Jul 27     Draft Guidance for Industry – 510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device.   The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.  The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device.  Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.  This document can be downloaded at:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm

Jul 26     Enforcement Reports - Drug Recalls

1. Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by recall notifications, dated May 5,                         2011.

Manufacturer: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL. Firm initiated recall is ongoing.

Products:  1) Q-Tussin DM (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-0855-58; UPC 3 0603-0855-58 1. Recall # D-714-2011;

2) CODITUSS DM liquid (Dextromethorphan HBr, USP, 10 mg per 5 mL; Phenylephrine HCl, 5 mg per 5 mL; Pyrilamine Maleate, 8.33 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0728-54; UPC 3 0603-0728-54 0. Recall # D-715-2011;

3) Q-Tapp liquid (Brompheniramine maleate, USP, 1 mg per 5 mL; Dextromethorphan HBr, USP, 5 mg per 5 mL; Pseudoephedrine HCl, USP, 15 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0852-94; UPC 3 0603-0852-94 8. Recall # D-716-2011

4) Iophen DM-NR (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-1330-58; UPC 3 0603-1330-58 2. Recall # D-717-2011

Lot codes:            1) Lot #: L145C10A, L028C10A; Exp 04/12;

2) Lot #: L089C10A, L089C10B, Exp 04/12;

                                         3) Lot #: L090C10A, Exp 04/12;

4) Lot #: L099D10A, L107C10A, L115C10A, Exp 05/13

Reason:   CGMP Deviations: These products have been manufactured with a lot of dextromethorphan   which was found to be out of specification for an impurity.

              2. Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, dba Qualitest Pharmaceuticals,                                                 Huntsville, AL by letters dated July 11 2011.

Manufacturers:  Time-Cap Laboratories Farmingdale, NY; Swiss Caps USA, Inc., Miami, FL Firm initiated recall is ongoing.

                   Products: 1) Bisacodyl delayed-release enteric coated tablets, USP, 5 mg, 100-count bottle, NDC 0603-                   2483-21, UPC 3 0603-2483-21 1. Recall # D-719-2011; Lot #: J071W, Exp 09/13;

                   2) Doc Q Lace (docusate sodium) softgels, 100 mg, 100-count bottle, NDC 0603-0145-21, UPC 3 0603-                   0145-217. Recall # D-720-2011;  2) Lot #: 103030, 103031, 103033, Exp 02/13; 103032, 104010,                                 104011, 104012, 104013, 104014, 105015, Exp 03/13; 105011, 105013, Exp 04/13                                               Reason:   Labeling:  Tablets/Capsule Imprinted with wrong I.D.: Incorrect product code printed on                    products.  

              3.  Recalling Firm: G & W Laboratories Inc., South Plainfield, NJ, by letters on April 21, 2011. Firm                       initiated recall is ongoing.

                  Product/Lot numbers:  G & W Bacitracin Ointment First Aid Antibiotic. Recall # D-713-2011;                           Lot # 028009009, Expiration Date July 2011; Lot # 028009006, Expiration Date May 2011

                  Reason:  Stability data does not support exp; failed 18-month stability test for microbiological assay. 

Jul 26     FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation.   FDA is taking this action as a result of two inspections of Cetero’s bioanalytical facility in Houston, Texas conducted in 2010, as well as the company’s own investigation and third party audit.  The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.  The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame.  FDA concurs with the assessment of Cetero’s independent auditor who stated, “This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also.”  As noted in a letter FDA sent to the company, Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations and failed to take sufficient measures to assure data integrity within the 5 year time frame.  As noted in the July 26 letter sent to Cetero, “FDA has reached this conclusion for three reasons: (1) the widespread falsification of dates and times in laboratory records for subject sample extractions, (2) the apparent manipulation of equilibration or ‘prep’ run samples to meet pre-determined acceptance criteria, and (3) lack of documentation regarding ‘prep’ runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations.”

Jul 26     Serious CNS Reactions Possible When Methylene Blue Is Given To Patients Taking Certain Psychiatric Medications.   On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications. Methylene blue is commonly used in diagnostic procedures and is also used to treat a number of medical conditions.
Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase a—an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms include mental changes including confusion, hyperactivity, and memory problems; muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.  Healthcare professionals and patients may not realize that methylene blue has MAOI properties. Methylene blue should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with methylene blue such as when it is used in the emergency treatment of:                                                                       

·         methemoglobinemia,

·         ifosfamide-induced encephalopathy, or

·         cyanide poisoning.

Safety information about these potential drug interactions and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications.   More at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266219.htm 

Jul 26     Zyvox (linezolid) Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications.   Linezolid should generally not be given to patients taking serotonergic drugs.  FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).  Linezolid is used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). It is a reversible monoamine oxidase inhibitor (MAOI). Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A — an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome — signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.

Jul 22     Enforcement Reports - Drug Recalls

1. Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on February 23, 2010..

Manufacturer: Teva Pharmaceutical Industries, Har Hozvim. Jerusalem, Israel. Firm initiated recall is ongoing..

                   Product:  Paroxetine Tablets USP, 20 mg, 90-count bottle, Rx only; NDC# 0093-7115-98. Recall # D-                   700-2011; Lot #: 07Y085

Reason:   CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".

               2. Recalling Firm: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN, by letter on                    July 7, firm initiated recall is ongoing.

                   Product:  Levoxyl (levothyroxine sodium) Tablets, USP, 75 mcg, 1000-count bottle, Rx only; NDC                    60793-852- 10; UPC 3 60793 85210 2. Recall # D-704-2011; Lot #: 60809, Exp 03/31/12

                   Reason:   Adulterated Presence of Foreign Tablets: The firm received a complaint of a single 200 mcg                    Levoxyl Tablet co-mingled in a 1000-count bottle of Levoxyl Tablets, USP 75 mcg.

               3. Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2011 and on                      April 22, 2011.

                   Manufacturer:  Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.

                   Product:  Cyclobenzaprine Hydrochloride 10 mg Tablets USP, 1000-count bottle, Rx only; NDC 50111-        563-03; UPC 3 50111-563-03 2. Recall # D-706-2011; Lot #: 703327, Exp 01/12; 315316, Exp 02/12

                   Reason:  CGMP Deviations: Some tablets may not conform to weight specifications.

               4. Recalling Firm/Manufacturer:  Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by letters on June 16,                            2011 and press release on June 17, 2011. Firm initiated recall is ongoing.

                   Products:  1) Risperidone Tablets 2 mg, 60 count bottles, Rx only, NDC 50458-593-60. Recall # D-709-                   2011; Lot # 0LG175, EXP 08-12;

                   2)  Risperdal Tablets (Risperidone), 3 mg, 60 count bottles, Rx only, NDC 50458-330-06. Recall # D-                   710-2011; Lot # 0GG904, Exp 05-12

                   Reason:  Chemical contamination; TBA 

               5. Recalling Firm: American Health Packaging, Columbus, OH, by letter on March 18, 2011.
                   Manufacturer: Impax Laboratories, Hayward, CA. Firm initiated recall is ongoing.

                   Product: Lofibra, Fenofibrate Capsules (Micronized), 200 mg, 30 UD, Rx only. NDC 0115-0533-01.                    Recall # D-701-2011; Lot #104122, and the Expiration Date: 05/31/2012

                   Reason:  Short fill; low-fill weight capsule.

6. Recalling Firm: Purdue Products L.P., Stamford CT, by letters dated April 27, 2011.

                   Manufacturer: Catalent Pharma Solutions, LLC, Saint Petersburg, FL. Firm initiated recall is ongoing.

                   Product:  Colace (docusate sodium) Stool Softener Capsules 100 mg, 30 count bottle, OTC, NDC 67618-        101-30. Recall # D-702-2011; Lot #: 0J8151, Exp 06/13

                   Reason:  Superpotent (Single Ingredient Drug): Colace (docusate sodium) stool softener 100 mg capsules                  are being recalled due to an out of specification result for the active ingredient. 

7. Recalling Firm:   Magno Humphries Inc., Tigard, OR, by telephone on February 24, 2009.

                   Manufacturer:  Aaron Industries Inc., Lynwood, CA. Firm initiated recall is ongoing.

                 Product:   Bi Mart Tussin DM, Cough Suppressant/Expectorant, 8 fl oz (237 ml), Dextromethorphan                   HBr, USP 10 mg, Guaifenesin USP 100 mg. UPC code: 0 71357 00190 3, Product label # G920l-008-ll-2.          Same lot from supplier packaged under a different lot numbers. Recall # D-712-2011;  Lot codes: 338495             and 338531, Exp date 08/10

                   Reason:   Presence of Precipitate: Tussin DM was observed with fibrous crystalline substance or floating                    material.

Jul 21    FDA Drug Safety Communication:  Ongoing Safety Review of Oral Osteoporosis Drugs (bisphosphonates) and Potential Increased Risk of Esophageal Cancer.   Bisphosphonates include the following products: Fosamax (alendronate), Fosamax-D, Actonel (risedronate), Actonel + Ca, Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), Reclast, Skelid (tiludronate), and Zometa.  One study found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs or who had taken the drugs over 3 years.  At this time the FDA believes the benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis outweighs the potential risks.  For more information go to:  http://www.fda.gov/Drugs/DrugSafety/ucm263320.htm

Jul 19    FDA Clinical Investigator Training Course.  The third annual FDA Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), is now open for registration.  DATES:  November 7 and 8, from 8 a.m. to 5 p.m. and on November 9, from 8 a.m. to 3:00 p.m.  LOCATION:  National Labor College, 10000 New Hampshire Avenue, Silver Spring, MD 20903.  REGISTRATION: Registration ends October 28, 2011.   COST:  $400.  Please find additional information at: http://www.fda.gov/Drugs/NewsEvents/ucm261639.htm

Jul 19     FDA Proposes Health Smartphone Application Guidelines   The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended.  The proposed guidelines⁷ were posted on the Federal Register website Thursday.  Consumers may weigh-in on the guidelines during a public comment period that ends Oct. 19.  For more information, visit the FDA’s Mobile Medical Apps page:   http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm

Jul 16     Drug Shortages – Amphetamine Mixed Salts, ER Capsules.  Shire’s Adderal XR capsules and Teva’s generic are in short supply due to active pharmaceutical ingredient supply issues.  Product will be released as it becomes available.  

Jul 13     Enforcement Reports - Drug Recalls

1.  Recalling Firm:  UDL Laboratories, Inc., Rockford, IL, by letter on March 7, 2011, April 8, 2011 and on April 28, 2011.                                                                                                                                                Manufacturer:   Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.                   Product/lot number:       1. Hydralazine HCl Tablets, USP 10 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-074-20. Recall # D-616-2011;  Lot 0P643, expiration date 01/12; lot 9V346, expiration date 06/11; lot 0J293, expiration date 12/11;

2) Hydralazine HCl Tablets, USP 50 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-076-20. Recall # D-617-2011; Lot 0S788, expiration date 05/12          Reason:   Tablet Thickness: Some tablets may not conform to weight requirements/specifications.

2.      Recalling Firm/Manufac, turer: Safecor Health, LLC, Woburn MA, by letter on March 2, 2011.  Firm initiated recall ongoing.                                                                                                                                   Product:  1) RE-PB Hyos Elixir,  5 mL and 10 mL Oral Syringes                                                                        2) Donnatal Elixir, 5 mL and 10 mL Oral Syringes                                                                               3) Levetiracetam Oral Solution, 5, 10, and 20 mL Oral Syringes                                                         4) Methadone HCl Oral Solution, 3 mL and 10 mL Oral Syringes                                                       5) Keppra (levetiracetam) Oral Solution, 1 mL and 5 mL Oral Syringe                                                6) Methadone HCl Oral Solution, 5 mL Oral Syringe                                                                     Reason: Container Leakage: Drug product may not contain the labeled volume/dose due to evaporation or leakage                                                                                                                                                                                                     

3.  Recalling Firm: Multimex, Tucker, GA, by press release on May 9, 2011 and by letter on May 11, 2011.             Manufacturers:  Goper's International LLC, San Diego, CA;  Multimex, Tucker, GA. Firm initiated recall is ongoing.                                                                                                                             Product/lot number:  1) Sinalar Decongestant and Nostrils Lubricant, Dropper with 0.50 oz., UPC 619114001006. Recall # D-624-2011; Lot #SINNA 1209;                                                                           2) Sinalar Inflammation and Infection of Ear, Dropper with 0.5 fl. oz., UPC 619114010036. Recall # D-625-2011; Lot #SINOT02-11;                                                                                                                    3) Sinalar Inflammation and Eye Infection, Dropper with 0.5 fl. oz., UPC 619114010029.  Recall # D-626-2011; Lot #SINOF02-11

                     Reason:   The products are misbranded and unapproved new drugs.                                                                                                                                                                 

4.   Recalling Firm:  Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on May 31, 2011.           Manufacturer:  Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.      Product/lot number:  Lansoprazole Delayed-Release Capsules USP, 30 mg, 30-count capsules, Rx Only, NDC 0093-7351-56. Recall # D-629-2011; Lot #'s: 44L031, 44L032, Exp 01/12

      Reason: Discoloration: Some capsules may not meet the appearance specifications; Pellet color varies from white to pink (pellet color spec is off-white to beige).

5.      Recalling Firm/Manufacturer:  Safecor Health, LLC, Woburn, MA, by letter dated March 21, 2011. Firm initiated recall is ongoing.                                                                                                             Product/lot number:    Sixty-six different  “Split Tab” products                                                                   Reason:  Marketed without an approved NDA/ANDA: Split tabs distributed as an unapproved new drug.

               6.  Recalling Firm/Manufacturer:  Impax Laboratories, Inc., Hayward, CA, by letters on June 22, 2011.                     Firm initiated recall is ongoing.                                                                                                                                  Product/lot number:  Dantrolene Sodium Capsules, 25 mg, Rx only 100 count HDPE bottle Recall #D-              696-2011; Lot number: 000073105, Exp. date: 04/12 and Lot number: 000074634, Exp. date: 08/12

                     Reason:  Subpotent; empty capsules found in one lot of Dantrolene Sodium Capsules, 25 mg.

               7.  Recalling Firm:  Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by                     press release on June 24, 2011 and by letters on June 27, 2011.                                                                                Manufacturer:  Qualitest Pharmaceuticals, Charlotte, NC. Firm initiated recall is ongoing.                                   Product:  1) Hydrocodone Bitartrate and Acetaminophen Tablets, USP, C-III, 7.5 mg/500 mg, 1000-                    count, Rx only, May be habit forming. NDC 0603-3882-32. Recall # D-698-2011;

                    2) Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50 mg/325 mg/ 40 mg, 500-count, Rx Only,                          NDC 0603-2544-28. Recall # D-699-2011

                    Lot numbers:  1) and 2) Lot #s: C0390909A; C0400909A; C0410909A; C0590909B, Exp. 03/12                       Reason:  Labeling: Ingredient mix-up due to mislabeling; Butalbital, Acetaminophen, and Caffeine                     Tablets, USP 50 mg/325 mg/40 mg may be mislabeled as Hydrocodone Bitartrate/Acetaminophen, 7.5                         mg/500 mg Tablets.

Jul  8      “Slim Forte Slimming Capsule” and “Slim Forte Double Power Slimming Capsules” Contain Undeclared Drug Ingredient.  FDA laboratory analysis confirmed that “Slim Forte Slimming Capsules” and “Slim Forte Double Power Slimming Capsules” contain sibutramine.  Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons.  These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  These products may also interact in life threatening ways with other medications a consumer may be taking.

Jul  7      Guidance for Industry: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259744.pdf

Jul  6      CDC Traveler’s Health: 2012 Yellow Book Now Available Online.  CDC Travelers’ Health is pleased to announce the online release of CDC Health Information for International Travel 2012 (widely known as the Yellow Book), the trusted travel medicine desktop reference for both health professionals and travelers. To view the online version of the Yellow Book or to order your own hard copy or e-book, visit the CDC Travelers’ Health website at www.cdc.gov/yellowbook .   The hard copy costs around $45.

Jul  5      FDA issues draft guidance on new dietary ingredients.  The purpose of this draft guidance is to clarify                agency expectations on new dietary ingredients for industry which is an important preventive control to                ensure that consumers are not exposed to unnecessary public health risks from new ingredients with                unknown safety profiles.  Dietary supplement manufacturers are required to notify the FDA in advance                when they intend to add a new dietary ingredient to their products, except in certain situations when the                ingredient has been part of the food supply and has not been chemically altered for use in supplements. The                notifications             must identify the new dietary ingredient and be accompanied by evidence on its safety. The      draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a    premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and                in preparing premarket safety notifications.  It can be found at:                http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupple               ments/ucm257563.htm

Jun 29    CDER Statement on Avastin Hearing.  The public hearing on the Center for Drugs’ December 2010 proposal to withdraw approval of the metastatic breast cancer indication for Avastin is now complete. The Center and Genentech are scheduled to provide additional written submissions by July 28, 2011, and the docket will remain open for public comment until that date.   Following the closing of the docket, the Center for Drugs will await Commissioner Hamburg’s final decision on Avastin’s use for metastatic breast cancer. The Commissioner’s decision related to breast cancer will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers. That is, regardless of the final decision on metastatic breast cancer approval, Avastin will remain on the market.

Jun 28    Guidance for Industry – Q11 Development and Manufacture of Drug Substances.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf

Jun 28    McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of Tylenol Extra Strength Caplets, 225 Count, Distributed in the U.S.   The recalled product (lot number ABA619) was manufactured in February, 2009.  McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).  This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.  Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com1 or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Jun 27   Recall:  Endocet (Oxycodone/Acetaminophen) Tablets, (10 mg/325 mg).  Endo Pharmaceuticals  and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, (10 mg/325 mg) because some bottles may contain different strength tablets, resulting in  patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.  The affected lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle.  Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.

Jun 27   Recall:  Butalbital, Acetaminophen, and Caffeine Tablets (USP 50 mg, 325 mg, 40 mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5 mg, 500 mg).  Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone. Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction.                                                                                                                           Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B                                                     Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B                                                                 These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Jun 27    New Guidance for Comment Only – Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h) of the Food and Drug Act.  This guidance is available for download at:  http://www.fda.gov/RegulatoryInformation/Guidances/ucm259059.htm

Jun 24    Resolved Drug Shortage – Thyroid (desiccated) Tablets.  Forest RLC announced that approved levothyroxine products are now available from multiple manufacturers.

May 27  Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.  Download at:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf

May 27  Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening of the Comment Period.  FDA is reopening the comment period for the notice of public workshop published in the Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA announced a public workshop that took place on February 15 and 16, 2011, and requested public comment regarding the topics discussed at the workshop on determining system attributes for tracking and tracing prescription drugs. The workshop provided a forum for discussing possible approaches to developing a track-and-trace system and for obtaining input from supply chain partners on potential attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages. FDA is reopening the comment period to allow additional time for interested persons both to consider all the information provided by the Agency related to the workshop and to submit additional comments. Submit either electronic or written comments by June 22, 2011. Additional information is provided in the Federal Register Notice at:  http://www.gpo.gov/fdsys/pkg/FR-2011-05-23/pdf/2011-12617.pdf

May 25  FDA Warns Not To Feed SimplyThick to Premature Infants.  The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.  FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 17 cases of NEC, including five deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.  FDA is actively investigating the link between SimplyThick and these illnesses and deaths. FDA will provide updates as information is made available.

May 24           FDA/DDMAC sends letter to Dr. Tanveer Ahmad at Noven Pharmaceuticals concerning Pexeva Tablets.    In it, DDMAC requests that Noven immediately cease the dissemination of violative promotional materials for Pexeva.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM256863.pdf

May 13  FDA Requests Input on Development of User Fee Program for Biosimilar and Interchangeable Biological Products.  Biological products are produced in a living system such as a microorganism, plant, or animal cell, while small molecule drugs are typically made through chemical synthesis.   For more information, including the Federal Register notice:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215031.htm

May 13  Guidance for Industry on theSubmission of Summary Bioequivalence Data for Abbreviated New Drug Applications.   This guidance document is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods.  The guidance provides information on the following subjects:   Types of ANDA submissions covered by the regulations on BE studies;  Recommended format for summary reports of BE studies; and Types of formulations the Agency considers to be the same drug product formulation for different dosage forms based on differences in composition.  Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2011-05-06/pdf/2011-11102.pdf

May 13  Guidance – Exception From Informed Consent For Emergency Research.  This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR).  This guidance finalizes the draft guidance entitled, "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research," dated July 2006 (published on August 29, 2006).  Guidance document:   http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf

May 11  Recall – Metformin Hydrochloride Tablets, 500 mg.  Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 23, 2011.  Lot # 35201115A, Exp 10/11.  Manufacturer: Novopharm Ltd., Scarborough Ontario, Canada. Firm initiated recall is ongoing.  Reason:  Failed Tablet Hardness: Some tablets may not meet friability specification.

May 10   Multi-Mex Distributor Inc. Recalls Dietary Supplements That May be Labeled as Antibiotic Drugs.

               The recall was initiated after an FDA inspection revealed the product packaging mimics antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.  Warnings of these dietary supplements made news in Texas on Thursday, April 28th, when four children were taken to a Medical Center due to worsening illnesses after being given dietary supplements the parents may have believed were antibiotics and which were packaged to resemble antibiotics that are readily available as over the counter drugs in Mexico. Giving the dietary supplement delayed legitimate medical treatment. Although the labels were printed in English and Spanish, the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers. It was determined the children had been given a dietary supplement, Amoxilina, which the parents may have believed was the antibiotic Amoxicillin.

May 9    FDA/DDMAC sends letter to Ms. Katie Cairati at ChemGenex Pharmaceuticals concerning Omapro for Injection.   In it, DDMAC requests that ChemGenex immediately cease the dissemination of violative promotional materials for Omapro.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM254614.pdf

May 9    FDA/DDMAC sends letter to Mr. Brian Deutsch at Warner Chilcott, LLC concerning Atelvia for Injection.  In it, DDMAC requests that Warner Chilcott immediately cease the dissemination of violative promotional materials for Atelvia.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM254562.pdf

May 3    FDA/DDMAC sends letter to Mr. John Driscoll at Forest Laboratories, Inc., concerning Savella Tablets.  In it, DDMAC requests that Forest Labs immediately cease the dissemination of violative promotional materials for Savella.  This correspondence is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM253625.pdf

.May 2   Bristol-Myers Squibb Initiates a Nationwide Recall of Coumadin (Warfarin Sodium) Crystalline     5 mg Tablets, Lot Number 9H49374A.  Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

May 2    FDA Approves New Treatment for Type 2 Diabetes.  The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.  People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.  Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.  Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.  Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

Apr 29   Ethos Environmental, Inc. Issues a Voluntary Recall of Specific Lots Of The Dietary Supplement Regenerect.  Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.  According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Apr 28   FDA approves Zytiga for late-stage prostate cancer.  The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).  In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.  Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.  The application was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Zytiga is being approved ahead of the product’s June 20, 2011 regulatory goal date.  The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.  Zytiga is marketed by Horsham, Pa.-based Centocor Ortho Biotech, Inc.

Apr 22   FDA/DDMAC sends letter to Kimberly A. Davis at Inspire Pharmaceuticals, Inc., concerning AzaSite (azithromycin ophthalmic Solution 1%)    In it, DDMAC requests that Inspire immediately cease the dissemination of violative promotional materials for AzaSite.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM252369.pdf

Apr 22            FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers.  The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.  Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of

May 2    FDA Approves New Treatment for Type 2 Diabetes.  The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.  People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.  Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.  Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.  Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

Apr 29   Ethos Environmental, Inc. Issues a Voluntary Recall of Specific Lots Of The Dietary Supplement Regenerect.  Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.  According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Apr 28   FDA approves Zytiga for late-stage prostate cancer.  The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).  In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.  Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.  The application was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Zytiga is being approved ahead of the product’s June 20, 2011 regulatory goal date.  The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.  Zytiga is marketed by Horsham, Pa.-based Centocor Ortho Biotech, Inc.

 Apr 22  FDA/DDMAC sends letter to Kimberly A. Davis at Inspire Pharmaceuticals, Inc., concerning AzaSite (azithromycin ophthalmic Solution 1%)    In it, DDMAC requests that Inspire immediately cease the dissemination of violative promotional materials for AzaSite.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM252369.pdf

Apr 22            FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers.  The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.  Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of

  Mar 2     FDA Prompts Removal of Unapproved Drugs From Market.  The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.  This is the final step in a long battle to force these products off the market that started in the mid-1980s.  The FDA’s actions accelerated with their Unapproved Drugs Initiative which began in June 2006.  The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.  Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC). Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.  In addition, the Federal Register Notice specifically addressed extended release products, tannates, and immediate release products.  More information can be found at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm                            A complete list of non-narcotic drugs effected can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm                                                             A list of enforcement actions by drug class can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm  

 Mar 1     Draft Guidance: "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)"    FDA has issued a draft guidance for industry entitled "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient for self-administration or to the patient's caregiver for administration to the patient. Second, the draft guidance addresses when a Medication Guide will be required as part of a REMS. The draft guidance is intended to answer questions that have arisen concerning these topics. This guidance document is located at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf

 Mar 1     OOPD/ORDR Course: "The Science of Small Clinical Trials"    FDA Office of Orphan Products Development (OOPD) and NIH's Office of Rare Disease Research (ORDR) are pleased to announce that registration is now open for their popular live/online course, "The Science of Small Clinical Trials," which will be offered at FDA's White Oak campus between April 19 and May 12 2011. Open to any interested person, this 8-lecture series can be attended in person or via the Internet, and will be presented by outstanding speakers from within and outside FDA/NIH.

This course deals with issues arising in the design and analysis of clinical trials based on small study populations. While small clinical trials are a necessity in the context of rare diseases, being able to conduct small trials with scientific rigor is of increasing importance in other contexts, particularly as genomic science begins to provide opportunities for individualized pharmacology. This course provides a broad overview of its subject, and does not require a strong mathematical background. It is not a high-level statistical seminar. Nor is it an introductory statistics course, assuming no prior knowledge whatsoever. The target audience is professionals with some awareness of basic statistical concepts who are interested in drug/device evaluation and regulatory affairs, in the context of small study populations (as for rare diseases, or personalized medicine).

You may find more information about the course at:   http://small-trials.keenminds.org/           

 Feb 25    E&J Brandy Announces A Nationwide Recall Of Stainless Steel Flasks Due To Possible Lead Risk   E&J Brandy announces the following voluntary recall. Consumers should immediately stop using the stainless steel flask sold in E&J® VSOP gift sets in 2006, 2007, 2008, 2009 and 2010 and in E&J® XO gift sets sold in 2006.  This voluntary recall pertains only to stainless steel flasks manufactured for E&J Brandy because laboratory results revealed that brandy stored in the flask under certain conditions may show elevated levels of lead.  Prolonged exposure to elevated levels of lead may have negative health effects.  This recall does not pertain to any bottles of E&J Brandy.
The affected flasks included in the 2006, 2007, 2008, 2009 and 2010 E&J® VSOP gift sets are silver, rectangular in shape and have “E&J VSOP” etched on the front.  The affected flasks included in the 2006 E&J® XO gift sets are silver and round in shape with “E&J” etched on the front.  These gift sets were sold throughout the United States through a variety of retail stores as recently as this past holiday season.  Some flasks in leather cases were also given away as a promotional item in 2007.
Consumers in possession of an affected stainless steel flask should call the consumer recall hotline at 1-866-959-8477 at any time for instructions on how to return the product and receive a full refund. The brandy contained in the gift set is unaffected and may be safely consumed but any brandy or other liquid in the flask should not be consumed. 

Feb 28    HHS Awards Contracts Totaling $215 Million to Develop New Flu Vaccine Technology   The U.S. Department of Health and Human Services (HHS) awarded two contracts today to help make vaccine available more quickly for seasonal flu outbreaks and pandemics. The contracts for advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine total $215 million  HHS awarded one contract to Novavax, Inc., of Rockville, Md., for $97 million over the first three years, which can be extended for an additional two years, for a total contract value of $179.1 million. HHS awarded a separate contract to VaxInnate, Inc. of Cranbury, N.J., for $117.9 million over the first three years, which can be extended for two additional years, for a total contract value of $196.6 million.  Under its contract, Novavax is to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.  VaxInnate is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.

Feb 22    Biotab Nutraceuticals, Inc. Issues Voluntary Recall of Specific Lots of the Nutritional Supplement Extenze (Men’s Regular) Due to Counterfeiting Biotab Nutraceuticals, Inc. (“Biotab”) is conducting a voluntary recall of two lots of EXTENZE nutritional supplement tablets. Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health.  Biotab learned about the problem after being notified by the Food and Drug Administration (FDA) that two lots of counterfeit product purporting to be EXTENZE contain undeclared drug ingredients. More specifically, lot 0709241 contains tadalafil and sildenafil, and lot 0509075 contains tadalafil and sibutramine. The counterfeit products are sold at retail nationwide in the form of carded four-packs (lot 0709241) and in the form of a box of thirty tablets divided into two fifteen tablet blister packs (lot 0509075).  Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED). These drugs may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek Extenze to enhance sexual performance.  Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.  The counterfeit Extenze product is not manufactured, distributed or packaged by Biotab, but is falsely marked with the same lot numbers used by Biotab for its genuine product. Because it is very difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two affected lots. It is possible that there may be other counterfeit products on the market that have yet to be identified.  Consumers in possession of product from the lots in question only should return any unused product to its immediate supplier for a direct refund. Customers with questions can call (626) 775-6334 Monday through Friday between 9 a.m. and 4 p.m. for further instructions or information with respect to the return and refund process. Additionally, Biotab will refund the supplier for any genuine (non-counterfeit) product returned to it.

Feb 18    Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall.  Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.  The expanded recall includes the following products:  Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin.  More information at:  http://www.fda.gov/Safety/Recalls/ucm244111.htm

Feb 17    Guidance for Industry:  Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.   It can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243702.pdf 

Feb 16    Guidance for Industry:  Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.  This guidance can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243537.pdf

Feb 16    Seizure:  U.S. Marshals Seize Unapproved Drug (Auralgan Otic Solution).  U.S. Marshals, at the request of the U.S. Food and Drug Administration yesterday, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky.  Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS.  Deston’s sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.  The value of the products seized is estimated to be $16.5 million.  On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs.  The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act.  Today’s action is part of the FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

Feb 15    HHS Announces $750 Million Investment in Prevention.   HHS announced a $750 million investment in prevention and public health, funded through the Prevention and Public Health Fund created by the new health care law. Building on $500 million in investments last year, these new dollars will help prevent tobacco use, obesity, heart disease, stroke, and cancer; increase immunizations; and empower individuals and communities with tools and resources for local prevention and health initiatives.

Feb 15   BARDA Supports Development of Drugs to Treat Radiation Injuries.  Two contracts for advanced development of drugs to treat skin and lung injuries associated with acute radiation syndrome (ARS) were awarded this week by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). These contracts are the first by BARDA to address the skin and lung injuries that arise from acute exposure to high levels of ionizing radiation – the type of radiation that results from a nuclear blast.  The contracts were awarded to Aeolus Pharmaceuticals Inc., of Mission Viejo, Calif., and U.S. Biotest Inc., of San Luis Obispo, Calif., and support research studies and manufacturing efforts by each company in developing their respective drugs.   The Aeolus contract is valued at $10.4 million for the first year and can be extended for a total of five years and up to a total of $118.4 million. Aeolus is developing a broad-spectrum antioxidant drug known as AEOL 10150. This drug was designed originally to reduce the damage caused by radiation during cancer treatments. For BARDA, the drug will be developed for use in treating lung injuries associated with acute radiation syndrome, known as pulmonary acute radiation syndrome or lung-ARS.  The U.S. Biotest contract is valued at $4.5 million for the first 16 months and could be extended for a total of five years and up to a total of $14 million. The contract with U.S. Biotest supports advanced development of DSC127, a drug applied to the skin to help body tissue heal after being exposed to ionizing radiation.   These contracts are part of the HHS radiological and nuclear threats preparedness strategy.

Feb 9      Recalls           Drugs – Class II                                                                                                                           1. Armour Thyroid (Thyroid Tablets, USP) ½ grain.                                                                Recalling Firm: Forest Pharmaceuticals.                                                                                                                     Numerous Lots                                                                                                                                        Reason:  Labeling: Label error on declared strength; some bottles are mislabeled as containing 1/2-grain tablets but actually contain 1-grain tablets. The entire lot is being recalled even though some bottles are labeled correctly because bottles of 1/2-grain and 1-grain could be shrink-wrapped together.

               Recalls           Drugs – Class III                                                                                                                   1. Lorazepam Tablets, USP, 0.5 mg, 1 mg, and 2mg.                                                                             Recalling Firm:  McKesson Packaging Services; Manufacturer Sandoz, Inc.                                   Numerous lots are recalled                                                                                                                                      Reason:  Impurities/Degrad, ation Products:  The product may not meet the specification for impurity levels throughout the assigned shelf life.                                                                                                                                                                                                                                                                             2.  Acyclovir Tablets 2 800 mg and Capsules 200 mg                                                                         Recalling Firm:  Teva Pharmaceuticals USA, Inc.                                                                                       200 mg: Lot # 35315261A, 35315263A, Exp 04/12;
800 mg: Lot # 35315369A, Exp 04/12                                                                                                   Reason: Presence of Foreign Substance: Presence of food grade gasket material may be present in the product.

               For more information go to: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm242808.htm                                                      

Feb 9      New Draft Guidance:  Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography (PET) Drug Products.  This draft guidance is intended to assist manufacturers of certain PET drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations.  The revised guidance is being issued again as a draft for comment because FDA’s perspective has changed significantly since issuance of the March 2000 draft guidance.  Guidance document can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

Feb 7      Recall – Incorrect Package Labeling:  1. Hydrocodone Bitartrate and Acetaminophen Tablets.                 2. Phenobarbital Tablets by Qualitest.   ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.                           As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.  The recall includes the following products:                                                                                                                                   Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A                                                                          Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A                                                                                                                  Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).                                                                                          RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement.  Lot numbers can be found on the side of the bottle.

Feb 4      Recall – Contamination:  Triad Alcohol Prep Product   Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.   

Feb 4      Recall – Undeclared Drug Ingredient:  Celerite Slimming Capsules.  Southampton, PA, Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contains an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement product Celerite™ Slimming Capsules are being recalled.  You can learn more at:  http://www.fda.gov/Safety/Recalls/ucm242199.htm

 Feb 4      FDA Approved Gardasil to Prevent Anal Cancer.   The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.  Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.  Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.  Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237941.htm

Feb 2      Drug Shortages – Discontinued Product:  Mebaral (mephobarbital 32 mg, 50 mg, and 100 mg tablets).   Lundbeck Inc. is no longer able to manufacture Mebaral CIV (brand of mephobarbital tablets, USP), and the company anticipates its limited remaining supply to be depleted by year end 2011. Once the current stock of Mebaral is depleted, Lundbeck will no longer be making product available. Due to the limited remaining Mebaral supply, we encourage patients to work with their physician to transition to alternative therapies rather than starting a new course of therapy with Mebaral.

Feb 1      FDA Has Published a PDUFA IV Information Technology Assessment for Fiscal Year 2010.

               You can download a copy from: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM241656.pdf

 Feb 1      The NDC Database file is updated Semimonthly.   It is available at:  http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

Jan 31    USDA and HHS Announce New Dietary Guidelines to Help Americans Make Healthier Food Choices and Confront Obesity Epidemic.  “The 2010 Dietary Guidelines are being released at a time when the majority of adults and one in three children is overweight or obese and this is a crisis that we can no longer ignore,” said Agriculture Secretary Tom Vilsack.  “These new and improved dietary recommendations give individuals the information to make thoughtful choices of healthier foods in the right portions and to complement those choices with physical activity.  The bottom line is that most Americans need to trim our waistlines to reduce the risk of developing diet-related chronic disease. Improving our eating habits is not on, ly good for every individual and family, but also for our country.”                   The new 2010 Dietary Guidelines for Americans focus on balancing calories with physical activity, and encourage Americans to consume more healthy foods like vegetables, fruits, whole grains, fat-free and low-fat dairy products, and seafood, and to consume less sodium, saturated and trans fats, added sugars, and refined grains.                                                                                                                                      More consumer-friendly advice and tools, including a next generation Food Pyramid, will be released by USDA and HHS in the coming months. Below is a preview of some of the tips that will be provided to help consumers translate the Dietary Guidelines into their everyday lives:                                            

·               Enjoy your food, but eat less.

·               Avoid oversized portions.

·               Make half your plate fruits and vegetables.

·               Switch to fat-free or low-fat (1%) milk.   

·               Compare sodium in foods like soup, bread, and frozen meals – choose foods with lower numbers.

·               Drink water instead of sugary drinks.                                                                                                    

More information at http://www.hhs.gov/news/press/2011pres/01/20110131a.html

Jan 27    Fourth FDA Orphan Drug Designation Workshop Scheduled for Feb 28 – March 1, 2011  The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.  Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing the drug. Orphan designation qualifies the applicant to receive certain benefits, such as tax credits and marketing incentives, from the federal government in exchange for developing the drug.                                                                                                     During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. FDA staff will provide one-on-one guidance to help participants develop strong applications. Designation requires there be a scientific rationale for expecting the proposed drug to be effective in the treatment, prevention, or diagnosis of that disease or condition.  More information can be found at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241230.htm

Jan 25    FDA has announced a revision to the Guidance for Industry:  Process Validation: General Principles and Practices (PDF 293 KB).  It can be downloaded from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

Jan 24    HHS releases $200 Million in Emergency Funding for States for Energy Assistance   .  The money is intended for use helping eligible low income homeowners and renters meet home energy costs.  For a complete listing of state allocations of funds released today go to: http://www.acf.hhs.gov/news/press/2011/fy11_liheap_funds.html.      

Jan 19    CDER Has Published a Guidance Agenda for 2011.  You can download it at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079647.pdf

Jan 19    FDA to Improve Most Common Review Path for Medical Devices.   The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.   Key actions include:

·               Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,

·               Clarifying when clinical data should be submitted in a premarket submission, guidance that will    increase the efficiency and transparency of the review process,

·               Establishing a new Center Science Council of senior FDA experts to assure timely and consistent          science-based decision making.

These actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).      Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.   These submissions are known as 510(k)s for the section of the Federal Food, Drug, and Cosmetic Act that describes this notification requirement. Generally, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.  Read more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm

Jan 18    New Guidance for Industry:   Size of Beads in Drug Products Labeled for Sprinkle (PDF – 44KB).  It can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243           

Jan 18   FDA Announces a PQRI Workshop:  Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP), February 22-23 2011, Hyatt Regency Bethesda.  Meeting information can be found at: http://www.pqri.org/pdfs/PODP_Workshop_final_02-11.pdf       

Jan 18   FDA is Announcing a Public Workshop entitled, “Determination of System Attributes for the Tracking and Tracing of Drugs”.  This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency’s goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.  The public workshop will be held on February 15 and 16, 2011.  Please find additional information about this workshop at: http://edocket.access.gpo.gov/2011/pdf/2011-72.pdf

Jan 18    A Draft Guidance for Industry is Being Circulated for comments on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.  This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008. To ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by March 8, 2011.  Please find additional information about this draft guidance at:   http://edocket.access.gpo.gov/2011/pdf/2011-94.pdf    

Jan 18    Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations.  This draft guidance document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA’s recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection. To ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by April 7, 2011.  Please find additional information about this draft guidance at: http://edocket.access.gpo.gov/2011/pdf/2011-73.pdf 

Jan 18   The FDA Data Standards Council Announced the 2011 Structured Product Labeling (SPL) Training Session Schedule.  The new schedule can be found at:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm

 Jan 18    The Federal Government Obtained Permanent Injunction Against Deltex Pharmaceuticals, Inc.  The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan. The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.  Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products.  Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements.  The consent decree also subjects the defendants to penalties of $2,500 per day if they fail to comply with any of the provisions of the consent decree, and an additional $500 for each violation.

 Jan 18   McNeil Consumer Healthcare Initiates Voluntary Recall of Certain OTC Products.  In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, ROLAIDS and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended.  Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com website or by calling our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Jan 12   Recalls

               1.  PRODUCT - LISINOPRIL
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx only; NDC 0172-3758-80. Recall # D-157-2011
CODE
Lot # TE03074, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated November 3, 2010.
Manufacturer: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Firm initiated recall is ongoing.
REASON
CGMP Deviations: some of the white tablets exhibit a blue discoloration.

               2.  PRODUCT - LIPITOR
Lipitor (atorvastatin calcium) tablets, 40 mg, 90 count bottle, Rx only, NDC 0071-0157-23. Recall # D-161-2011  
CODE
Lot # 0836050, Exp 04/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter and press release on December 17, 2010.
Manufacturers: Pfizer Ireland Pharmaceuticals, Cork, Ireland;
Pfizer Manufacturing Deutschland Gmbh, Freiburg, Germany;
Rexam, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.       3.  PRODUCT – METOPROLOL TARTRATE
1) Metoprolol Tartrate Tablets, USP, 50 mg, a) 100 count bottles (NDC 0781-1223-01), b) 1000 count bottles (NDC 0781-1223-10), Rx only. Recall # D-162-2011;                                                                      2) Metoprolol Tartrate Tablets, USP, 100 mg, a) 100 count bottle (NDC 0781-1228-01), b) 1000 count bottles (NDC 0781-1228-10), Rx only. Recall # D-163-2011
CODE  Too numerous to list
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 5, 2011. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements: Metoprolol batches may exhibit non-homogenous granulation.

               4.  PRODUCT - EQUALINE BRAND OF RANITIDINE
Equaline Maximum Strength Heartburn Relief Ranitidine tablets USP 150 mg acid reducer, OTC, 1) 50 tablets (doses), NDC 41163-404-50, 2) 65 tablets (65 doses), NDC 41163-404-61. Recall # D-156-2011
CODE
Lot number: 7945253B, Exp 07/12; 7945253C, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy's Laboratories Inc., Bridgewater, NJ, by letter on November 15, 2010.   
Manufacturer: Dr. Reddy's Laboratories Louisiana LLC. Shreveport, LA. Firm initiated recall is ongoing.
REASON
Label Error on Declared Strength: Ranitidine tablets carton states 'Compare to Zantac 75' whereas it should state "Compare to Zantac 150'.  

 5.      PRODUCT -  SE-NATAL 19, SE-NATAL 90, AND SETON ET-EC
Se-Natal 19 Chewable Tablets; Vitamins and Minerals with Folic Acid; 100 tablets; Rx only; NDC #13925-01-1701. Recall # Recall # D-158-2011;                                                                                                2) Seton ET-EC Tablets, NDC # 13925-10-1060; this product is package in bulk containers. Firm states they do not have a label available for this product since it is in bulk. It is a Prenatal Multivitamin and Minerals with Iron and Folic Acid. Recall # D-159-2011;                                                                                 3) Se-Natal 90 Prenatal Multivitamin/Mineral Tablets; 100 tablets; Rx only; NDC # 13925-102-01. Recall # D-160-2011
CODE
1) Lot # 906020, Exp 04/11;
2) Lot # 903021, Exp 04/11;
3) Lot # 904083, Exp 04/11
RECALLING FIRM/MANUFACTURER
Rasi Laboratories, Inc., Somerset, NJ, by letters on September 23, 2010 and October 21, 2010. Firm initiated recall is ongoing.
REASON
Superpotent Multiple Ingredient Drug: Prescription prenatal vitamins do not meet the product specifications for iron due to its high content and ascorbic acid due to its low content.

Jan 13   The Latest Cumulative Supplement of the Orange Book is Available.  You can download at:   http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf

Jan 13    FDA Limits Acetaminophen in Prescription Combination Products: Requires Liver Toxicity Warnings.   The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Jan 12    Public Notification:  “Celerite Slimming Capsules” Contains Undeclared Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Celerite Slimming Capsules,” a product for weight loss sold on various websites, such as www.celeriteweightloss.com.  Claims made for the product falsely state that it is “safe” and an “all-natural herbal weight loss remedy.”  FDA laboratory analysis confirmed that “Celerite Slimming Capsules” contain sibutramine. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.  This product may also interact in life threatening ways with other medications a consumer may be taking.  This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

 Jan 12     Legionnaires’ Disease in Cozumel, Mexico.  An outbreak of Legionnaires’ disease is ongoing at the Regency Club Vacation Resort and Wyndham Cozumel Resort & Spa (formerly Reef Club Cozumel), a hotel complex, on the island of Cozumel, Mexico. Since May 2008, there have been a total of nine confirmed cases of Legionnaires’ disease among tourists from the United States and the Netherlands who have stayed at this resort.  Based on findings from a public health investigation in April 2010, disinfection of the resort’s shared potable water system was recommended. Although measures were taken at the resort to disinfect the water system, in December 2010, CDC was notified of the ninth case associated with the resort, suggesting that there is an ongoing source of exposure.  Symptoms begin 2–14 days after exposure and include high fever, cough, and shortness of breath. Many people also have diarrhea, headaches, or muscle aches. Legionnaires’ disease can be a severe and fatal illness but most persons will recover with appropriate antibiotic treatment.

 Jan 11    Update from CDER, FDA/CMS Meeting last December, Janet Woodcock, M.D.   The slides from her presentation may be viewed at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM239634.pdf

Jan 10   FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain.  The U.S. Food and Drug Administration approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.  Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where , they dissolve and are absorbed.

Jan 7      FDA Warns Public of Continued Extortion Scam by FDA Impersonators.  The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued  international extortion scam.  The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.  The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm and/or incarceration.  "Impersonating an FDA official is a violation of federal law," said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action.”  In most instances, victims of extortion-related calls have also received telephone solicitations for additional pharmaceutical purchases from other possibly related, illegal entities located overseas. The extortionists use customer lists complete with extensive personal information provided through previous purchase transactions. These include names, addresses, telephone numbers, Social Security numbers, dates of birth, purchase histories and credit card account numbers.  Typically, these criminals use telephone numbers that change constantly and make it appear as though their calls originate in the United States.

Jan 6      FDA Basics For Industry Web Page.   FDA has introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency. FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

 Jan 5      Recalls                                                                                                                                                           1.  PRODUCT -  Lorazepam                                                                                                               Lorazepam Tablets, USP, 0.5 mg. Packaged in 100 ct bottles (NDC 0781-1403-01) and 500 ct bottles (NDC 0781-1403-05).  Recall # D-132-2011;                                                                                       Lorazepam Tablets, USP, 1 mg. Packaged in 100 ct bottles (NDC 0781-1404-01) and 500 ct bottles (NDC 0781-1404-05). Recall # D-133-2011;                                                                                         Lorazepam Tablets, USP, 2 mg, a) 100-count bottles (NDC 0781-1405-01); b) 500-count bottles (NDC 0781-1405-05), Rx only. Recall # D-134-2011                                                                              CODE  - numerous lots                                                                                                         RECALLING FIRM/MANUFACTURER                                                                                   Sandoz Inc., Broomfield, CO, by letter on November 16, 2010. Firm initiated recall is ongoing.        REASON                                                                                                                      Impurities/Degradation Products: Lorazepam tablets were out of specification for Related Compound-C prior to expiry.

Jan 5      Drug Shortages -  Avalide (Irbesartan and hydrochlorothiazide) Tablets.   Bristol-Myers Squibb claims manufacturing delays at contract manufacturer.  No date of release known at this time.

Dec 22   Recalls                                                                                                                                           PRODUCT – Abilify Discmelt (aripiprazole) Tablets                                                                     Abilify Discmelt (aripiprazole) Tablets, 10 mg, 30 tablets count cartons, Packaged in 3 blister cards with 10 tablets in each blister card; NDC 59148-640-23. Recall # D-125-2011;                                         Abilify Discmelt (aripiprazole) Tablets, 15 mg, 30 tablets count cartons, Packaged in 3 blister cards with 10 tablets in each blister card; NDC 59148-641-23. Recall # D-126-2011                                        CODE                                                                                                                                                     Lot numbers: 9K57914A, Exp date: 11/12; and 0A60408A, Exp date: 01/13;                                                Lot number: 9K57907A, Exp date: 11/12                                                                                  RECALLING FIRM/MANUFACTURER                                                                               Recalling Firm: Bristol-Myers Squibb Company, Inc., Mount Vernon, IN, letters dated October 11, 2010.                                                                                                                                     Manufacturer: Bristol Myers Squibb Manufacturing Co., Humacao, PR. Firm initiated recall is ongoing. REASON                                                                                                                                         Marketed Without an Approved NDA/ANDA: Abilify Discmelt Orally Disintegrating Tablets 10 mg and 15 mg were packaged and released with 3 ply aluminum blister foil. The 3 ply foil is not the current NDA approved foil.

Dec 21   Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.   This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. It provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. It is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.  Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 14, 2011.  Please find additional information at:

http://edocket.access.gpo.gov/2010/pdf/2010-31426.pdf  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf

 Dec 16   Prescription Drug User Fees (PDUFA) for 2011.   The FDA has announced the prescription drug user fees for 2011.  You can download the rates at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2010_register&docid=fr04au10-70.pdf .  Briefly they are:

               Applications Requiring Clinical Data $1,542,000

               Applications Not Requiring Clinical Data $771,000

               Supplements Requiring Clinical Data $771,000

               Establishments $497,200

               Products $86,520

 Dec 16  The Process for Removing the Breast Cancer Indication for Avastin Has Begun.  FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Dec 15   FDA: Tainted products marketed as dietary supplements potentially dangerous.  In a letter sent today to dietary supplement manufacturers, the U.S. Food and Drug Administration expressed concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements. These substances include the active ingredients in FDA-approved drugs or their analogs (closely-related drugs), or other compounds, such as novel synthetic steroids, that do not qualify as dietary ingredients.                                                                                                                                     FDA has noted the three most common categories of these illegal products:

1.  Weight loss products containing active ingredients such as sibutramine: Sibutramine is the active ingredient in the drug Merida, which was recently withdrawn from the market due to increased risk of heart attack and stroke. The FDA has discovered dozens of products, such as Slimming Beauty, Solo Slim, Slim-30, and others, which contain sibutramine or closely related drugs (analogs).

2.  Body-building products containing anabolic steroids or steroid analogs: These products can cause acute liver injury and increase the risk for heart attack, stroke and death. Products like Tren Xtreme, ArimaDex, and Clomed have been labeled to contain either anabolic steroids or aromatase inhibitors, which prevent anabolic steroids from being converted to estrogen.

3.  Sexual enhancement products that contain the same active ingredient or an analog of the active ingredient in the approved drugs Viagra, Cialis, and Levitra. The approved products are available only by prescription, and they should not be used by people who have certain medical conditions, such as cardiovascular disease. Products determined to be in violation of federal law by the FDA include Vigor-25, Duro Extend Capsules for Men, Magic Power Coffee, and others.                                              FDA’s Current Good Manufacturing Practices require dietary supplement manufacturers to have proper manufacturing and quality assurance controls in place to ensure the quality of their products, including controls to prevent the inclusion of contaminants that could adulterate their products.

Dec 15   Draft Guidance Now Available:  Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.   A copy can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf

Dec 14   Recall:  McNeil Consumer Products in the News Again!                                                                   ISSUE: McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. recalled all lots of Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas Softchews distributed in the United States, following consumer reports of foreign materials in the product, including metal and wood particles.                                                                                  BACKGROUND: The company’s investigation determined that the materials were potentially introduced into the product during the manufacturing process at a third party manufacturer. While the investigation is ongoing, production of these products has been suspended and will not restart until corrective actions have been implemented.                                                                                                                                                               RECOMMENDATION: Consumers who purchased product included in this recall should contact McNeil Consumer Healthcare, either at http://www.rolaids.com  or by calling 1-888-222-6036 for instructions about receiving a refund. Consumers who have medical concerns or questions should contact their healthcare provider.

 Dec 14    FDA says Tessalon liquid cough capsules pose risk for young children.  Medication has candy-like appearance; should be kept in child-proof container. The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.                                                                                                           Tessalon, approved by the FDA to treat symptomatic relief of cough in patients older than 10, may attract younger children because of the drug’s candy-like appearance – a round, liquid-filled gelatin capsule. The safety and effectiveness of benzonatate in children younger than 10 years has not been established.                                                                                                                                           Common adverse events reported in the overdose cases included cardiac arrest, coma, and convulsion. Signs and symptoms of overdose can occur within 15-20 minutes of ingestion. Some of the deaths reported in children have been within hours of the accidental ingestion. 

Dec 10   HHS Makes Available More Than $670 Million in Additional LIHEAP Funding.  The U.S. Department of Health and Human Services today announced the availability of more than $670 million to states to help low income families with their heating bills this winter. These funds represent additional grants to states, tribes and territories under the Low Income Home Energy Assistance Program (LIHEAP).  The funds released today are in addition to the $2 billion that were made available to states in October after the first continuing resolution was enacted for fiscal year 2011.  With this release, a total of $2.7 billion is currently available to states for heating assistance needs in FY 2011, which began October 1, 2010.  States receiving the most funds are: NY $277 million, PA $160 million, IL $136 million, OH $132 million, MI $130 million, and CA $118 million.  States receiving the least were Alaska and Wyoming as well as the District of Columbia.

Dec 10   The NIOSH Science Blog has been updated: Warning: Surgeon General Finds Tobacco is Even More Dangerous to Your Health.  Yesterday, the Surgeon General issued the 30th Surgeon General’s Report on the dangers of smoking tobacco. Tobacco use remains the leading cause of preventable death in the United States, and is responsible for 443,000 deaths each year.  Tobacco use can increase risk of illness for those exposed to carcinogens in the workplace and second-hand smoke can place non-smoking workers at risk for smoking-related diseases. 

Dec 8     FDA’s Emergency Telephone Number Has Been Changed.   As of December 10, 2010, the former FDA 24-hour emergency number, 301-443-1240, will be disconnected.  The new numbers for the Office of Emergency Operations will be 1-866-300-4374 or 301-796-8240.

These numbers can be used to report the following types of problems to FDA:                               A serious, life-threatening event involving an FDA-regulated product, i.e., foods, dietary supplements, cosmetics, human drugs animal drugs, medical devices, biological products, and radiation-emitting electronic products                                                                                           Requests from medical professionals for approval for the use of an emergency investigational new drug, device or biologic.                                                                                     Notifications to FDA from government agents acting in an official capacity about an urgent matter. Reports of an emergency involving an FDA employee or an FDA employee's family member. Reports of a non-life threatening adverse reaction to an FDA-regulated product that requires immediate reporting.

Dec 8     Bayer Announces Voluntary Recall of 81 mg and 325 mg Aspirin Enteric Coated Tablets.   NDC Numbers are 0280-2100-01 and 0280-2110-01 respectively.  1) Lot Numbers: 205190B, Exp: 1/12; 204890B, Exp: 1/12; 201739P, Exp: 11/11; 293199H, Exp: 6/11; 286209C, Exp: 1/11, and 284019B, Exp: 1/11; and 2) Lot numbers: 207500C, Exp: 1/12; 201839P, Exp: 10/11.  Reason: failed dissolution test requirements – out of specification dissolution.

Dec 8     Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products.   FDA is announcing the availability of a guidance for industry entitled ‘‘ANDAs: Impurities in Drug Products.’’ This guidance updates recommendations regarding degradation products and updates the draft guidance ‘‘ANDAs: Impurities in Drug Products’’ announced in December 1998 in conformance with the revision of the International Conference on Harmonisation (ICH) guidance for industry ‘‘Q3B(R) Impurities in New Drug Products,’’ which was announced in August 2006.  Download at:  www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072861.pdf     

Dec 8     Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.    FDA is also announcing the availability of a guidance for industry entitled ‘‘Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.’’ The purpose of this guidance is to provide information on FDA’s current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency’s thinking in this area has evolved in recent years in response to a number of public discussions on the use of active controlled trials designed to show NI as the basis for approval of antibacterial drug products. This guidance finalizes the draft guidance published in the Federal Register of October 15, 2007.  Download at:  www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070951.pdf

Dec 6     Intelli Health Products Issues an Expansion to All Lots of Their Voluntary Nationwide Recall of Duro Extend Capsules for Men Marketed as Dietary Supplements.   Intelli Health Products announced today that it is expanding their voluntary nationwide recall of Duro Extend Capsules For Men, to include all lot codes. Intelli Health Products is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men found the product to be adulterated with Sulfoaidenafil, an analogue of Sildenafil which is an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making it an unapproved new drug.                             &, nbsp;                                                                                                  

Dec 3     Drug Shortages – Levorphanol 2 mg Tablets.   Roxane Laboratories announced the shortage of their Levorphanol 2 mg Tablets due to manufacturing delays.  The product is anticipated soon.

Dec 2    Guidance for Industry – Bioequivalence Recommendations for Specific Products.  It can be downloaded at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf   

Dec 1     Recall of Mylanta and Alternagel Liquid Products.  In consultation with the U.S. Food and Drug Administration (FDA), Johnson & Johnson-Merck Consumer Pharmaceuticals, Co. (JJMCP) is recalling, from the wholesale and retail level, twelve MYLANTA® liquid products and one AlternaGEL® liquid product. JJMCP is conducting the recall in order to update the labeling for these products.  JJMCP initiated the recall after an internal review revealed that information about the presence of alcohol from flavoring agents was not noted on the packaging. Certain flavoring agents contribute small (< 1%) amounts of alcohol. It is unlikely that use of these products will cause either alcohol absorption or alcohol sensitivity related adverse events.  This is a wholesale and retail level recall and is not being undertaken on the basis of adverse events. No action is required by consumers or healthcare providers and consumers can continue to use the product.

 Nov 27   Recall of Children's BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets.   In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States. This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil's Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.

Nov  23  Prescription Drug User Fee Act; Reopening of the Comment Period.   FDA is reopening until October 31, 2011, the comment period for the notice of public meeting that published in the Federal Register of March 16, 2010 (75 FR 12555). In the notice, FDA announced a public meeting to solicit input on the reauthorization of the Prescription Drug User Fee Act (PDUFA) program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires public review of the recommendations for the human drug review program after negotiations with the regulated industry conclude. FDA expects that this additional public process will be complete by October 2011. FDA is reopening the comment period for the expected duration of the public part of the reauthorization process to ensure that all interested stakeholders have the opportunity to share their views on the matter.   In the Federal Register of March 16, 2010 (75 FR 12555), FDA published a notice of a public meeting on PDUFA reauthorization and invited comments. In the notice, the Agency stated that the authority for PDUFA expires in September 2012. Without new legislation, FDA will no longer be able to collect user fees to fund the human drug review process. Section 736B(d)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires that before FDA begins negotiations with the regulated industry on PDUFA reauthorization, we do the following:                         (1) Publish a notice in the Federal Register requesting public input on the reauthorization,                                    (2) hold a public meeting at which the public may present its views on the reauthorization,                                  (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and                                                                                                                                            (4) publish the comments on the FDA Web site.                                                                                                      The public meeting was held on April 12, 2010, and interested persons were given until May 12, 2010, to submit comments. The written comments submitted during that period are now published on the FDA Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm215804.htm.      You may find additional information at: http://edocket.access.gpo.gov/2010/pdf/2010-28357.pdf                                                                                                                                                             

Nov 23   Some “Lead Free” Pottery Can Still Taint Food.   Colorful pottery may look nice on the dining room table. But beware: it can cause serious harm if it can contaminate food placed in it with lead.  Although we're all exposed to small amounts of lead during our daily routine, exposure to large amounts can cause lead poisoning, a dangerous condition that occurs when the body absorbs lead into the bloodstream.  The Food and Drug Administration (FDA) says it has confirmed reports from local and state agencies that traditional ceramic pottery made by several manufacturers in Mexico—and labeled “lead free”—in fact contains lead.  You can read more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233531.htm

 Nov 19   Xanodyne agrees to withdraw propoxyphene from the U.S. market.  Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well. The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).  Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.  In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.  The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm

Nov 9     Pharmaceutical Company Lawyer Charged with Obstruction and Making False Statements.   WASHINGTON – An attorney for a major pharmaceutical company was charged with obstruction and making false statements, the Justice Department announced today. Lauren Stevens of Durham, N.C., was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).   The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.   Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. Charges contained in the indictment are simply accusations, and not evidence of guilt.  The pharmaceutical company for whom Stevens worked has not been charged with a crime and was not identified in the indictment

Nov 4     FDA Claims Very Low Health Risks from Full-Body X-ray Scanners.   Be it in airports, court buildings, or other venues, Americans are increasingly encountering full-body imaging systems, the new wave in electronic security screening.  General-use X-ray security screening systems represent one of two full-body scanning technologies currently being put into widespread use to check people for  weapons, explosives, or other contraband without having to make physical contact. Extensive use of full-body scanning technologies, including the general-use X-ray systems, is a relatively new development. Thus it's natural for people to have questions—including questions about whether these systems pose any health risks.  However, FDA Engineer Daniel Kassiday says, "The dose from one screening with a general-use X-ray security screening system is so low that it presents an extremely small risk to any individual.”  (Editor’s note:  Radiation from each screening is cumulative.  Multiple screenings increase your risk.  On top of that there is the increased radiation you are exposed to during flight. My recommendation is let others do it for the next five years, then decide if it is safe for you!)   

 Nov 27   Recall of Children's BENADRYL® Allergy FASTMELT® Tablets and Junior Strength MOTRIN® Caplets.   In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of all product lots of Children's BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States, Belize, Barbados, Canada, Puerto Rico, St. Martin, and St. Thomas and all product lots of Junior Strength MOTRIN® Caplets, 24 count, that were distributed in the United States. This is a wholesale and retail level recall. No action is required by consumers or healthcare providers and consumers can continue to use the product. The recall was initiated after a review, conducted as part of McNeil's Comprehensive Action Plan, revealed insufficiencies in the development of the manufacturing process. There is no indication that the recalled products do not meet quality standards, and this recall is not being undertaken on the basis of adverse events.

Nov  23  Prescription Drug User Fee Act; Reopening of the Comment Period.   FDA is reopening until October 31, 2011, the comment period for the notice of public meeting that published in the Federal Register of March 16, 2010 (75 FR 12555). In the notice, FDA announced a public meeting to solicit input on the reauthorization of the Prescription Drug User Fee Act (PDUFA) program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires public review of the recommendations for the human drug review program after negotiations with the regulated industry conclude. FDA expects that this additional public process will be complete by October 2011. FDA is reopening the comment period for the expected duration of the public part of the reauthorization process to ensure that all interested stakeholders have the opportunity to share their views on the matter.   In the Federal Register of March 16, 2010 (75 FR 12555), FDA published a notice of a public meeting on PDUFA reauthorization and invited comments. In the notice, the Agency stated that the authority for PDUFA expires in September 2012. Without new legislation, FDA will no longer be able to collect user fees to fund the human drug review process. Section 736B(d)(2) (21 U.S.C. 379h-2(d)(2)) of the FD&C Act requires that before FDA begins negotiations with the regulated industry on PDUFA reauthorization, we do the following:                         (1) Publish a notice in the Federal Register requesting public input on the reauthorization,                                    (2) hold a public meeting at which the public may present its views on the reauthorization,                                  (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and                                                                                                                                            (4) publish the comments on the FDA Web site.                                                                                                      The public meeting was held on April 12, 2010, and interested persons were given until May 12, 2010, to submit comments. The written comments submitted during that period are now published on the FDA Web site at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm215804.htm.      You may find additional information at: http://edocket.access.gpo.gov/2010/pdf/2010-28357.pdf                                                                                                                                                             

Nov 23   Some “Lead Free” Pottery Can Still Taint Food.   Colorful pottery may look nice on the dining room table. But beware: it can cause serious harm if it can contaminate food placed in it with lead.  Although we're all exposed to small amounts of lead during our daily routine, exposure to large amounts can cause lead poisoning, a dangerous condition that occurs when the body absorbs lead into the bloodstream.  The Food and Drug Administration (FDA) says it has confirmed reports from local and state agencies that traditional ceramic pottery made by several manufacturers in Mexico—and labeled “lead free”—in fact contains lead.  You can read more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm233531.htm

 Nov 19   Xanodyne agrees to withdraw propoxyphene from the U.S. market.  Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well. The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).  Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.  In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug’s cardiac effects would be relevant in weighing its risks and benefits.  Th, e agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm

Nov 9     Pharmaceutical Company Lawyer Charged with Obstruction and Making False Statements.   WASHINGTON – An attorney for a major pharmaceutical company was charged with obstruction and making false statements, the Justice Department announced today. Lauren Stevens of Durham, N.C., was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).   The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.   Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. Charges contained in the indictment are simply accusations, and not evidence of guilt.  The pharmaceutical company for whom Stevens worked has not been charged with a crime and was not identified in the indictment.

 Nov 4     FDA Claims Very Low Health Risks from Full-Body X-ray Scanners.   Be it in airports, court buildings, or other venues, Americans are increasingly encountering full-body imaging systems, the new wave in electronic security screening.  General-use X-ray security screening systems represent one of two full-body scanning technologies currently being put into widespread use to check people for  weapons, explosives, or other contraband without having to make physical contact. Extensive use of full-body scanning technologies, including the general-use X-ray systems, is a relatively new development. Thus it's natural for people to have questions—including questions about whether these systems pose any health risks.  However, FDA Engineer Daniel Kassiday says, "The dose from one screening with a general-use X-ray security screening system is so low that it presents an extremely small risk to any individual.”  (Editor’s note:  Radiation from each screening is cumulative.  Multiple screenings increase your risk.  On top of that there is the increased radiation you are exposed to during flight. My recommendation is let others do it for the next five years, then decide if it is safe for you!)  

Oct 29    FDA Approves Teflaro for Bacterial Infections.   The U.S. Food and Drug Administration today approved Teflaro (ceftaroline fosamil), an injectable antibiotic to treat adults with community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA).  Teflaro is an antibacterial agent in a class of drugs known as cephalosporins, which act by interfering with the bacterial cell wall.  Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231594.htm

Oct 29   Heparin Sodium Recall.   B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.  Heparin is a blood thinner used to treat and prevent blood clots.  Customers who have product from the recalled product lots in their possession should discontinue use immediately.  No list of recalled lots was included in the press release.

Oct 29    Methotrexate Injection, 50 mg/2 mL and 250 mg/10 mL Vials: Recall.   Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.  Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.  Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

Oct 29    Hyland’s Teething Tablets May Pose Poisoning Risk.  The FDA has found up to 16 times the amount of belladonna alkaloids in these tablets.  Discard unused product immediately and contact your physician if your child is experiencing flushing, dilated pupils, drowsiness, irritability, constipation, decreased urine volume, enlarged bladder, or seizures.  Video at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm231356.htm   

Oct 28    HHS Announces Nearly 700 Additional Employers and Unions To Receive Help Providing Health Coverage To Early Retirees and Their Families.   The U.S. Department of Health and Human Services (HHS) today released a list of additional employers and unions accepted into the Affordable Care Act’s Early Retiree Reinsurance Program. Nearly 700 additional large and small businesses, state and local governments, educational institutions, non-profit organizations, and unions have been accepted into the program, which reimburses employers for a portion of the cost of health benefits for early retirees’ and their families. Today’s announcement brings the total number of organizations participating in the program to nearly 3,600.  More information about the Early Retiree Reinsurance Program, a full alphabetical list of participants, and an interactive map displaying participants by state is available online.  This list is updated regularly.  To find this information, please visit:
http://www.healthcare.gov/news/factsheets/early_retiree_reinsurance_program.html.

Oct 27    FDA Awards $18.5 Million in Grants for Food and Feed Safety.   The U.S. Food and Drug Administration awarded 84 grants worth $18.5 million in fiscal year 2010 to help state and local regulatory agencies defend against and respond quickly to threats to the food supply and to outbreaks of foodborne diseases. The grants fund major cooperative agreements in four major areas: response, intervention, innovation, and prevention.  For more information go to:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm231204.htm

Oct 26    The FDA Is Announcing the Availability of a Draft Guidance for Industry Entitled, “Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without An IND”.  This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an IND. The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND requirements. Although you can comment on any guidance at any time, to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 12, 2011. Submit either electronic or written comments concerning proposed collection of information by December 13, 2010. You may find additional information about this draft guidance document and information on how to submit comments at: http://edocket.access.gpo.gov/2010/pdf/2010-25851.pdf

Oct 26    HHS Announces Availability of $3.9 Million To Support Families of Children With Special Health Care Needs.  The HHS today announced $3.9 million in funding to continue support for Family-to-Family Health Information Centers, non-profit organizations run by families and for families with children with special health care needs.  Funding for the centers was extended through 2012 by the Affordable Care Act.  Created in 2005, Family-to-Family Information Centers provide information, education, training, outreach, and peer support to families of children and youth with special health care needs and the professionals who serve them. The centers are operated by family leaders who have children with special health care needs and expertise in federal and state public and private health care systems, as well as by health professionals. HHS’ Health Resources and Services Administration (HRSA) oversees the program.  The funding will continue support for Family-to-Family Health Information Centers located in 40 states and the District of Columbia. Centers in the remaining ten states (Alaska, Alabama, Arkansas, Iowa, Idaho, Kentucky, Ohio, South Carolina, West Virginia and Wyoming) were funded during fiscal year 2009.  Because they are in their second year of three-year funding, they are not eligible for this funding opportunity.  For more information on the program, and other HRSA maternal and child health programs, visit www.mchb.hrsa.gov/.  To view this funding announcement, visit www.grants.gov and enter announcement number “HRSA-11-035.”  For more information on finding health coverage options for children, visit www.InsureKidsNow.gov. 

Oct 26    HHS Announces Availability of up to $335 Million to Boost Access to Primary Health Care.   The HHS today announced the availability of up to $335 million for existing community health centers across the country under the Expanded Services (ES) initiative. These funds are made possible by the Affordable Care Act and will increase access to preventive and primary health care, including dental health, behavioral health, pharmacy, vision, and/or enabling services, at existing health center sites.  For grant application information, please visit bphc.hrsa.gov/es/. Applications are due January 6, 2011 at 8 P.M. E.T.

Oct 25    FDA Laboratory Receives Accreditation.  The U.S. Food and Drug Administration today announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System program in the Center for Biologics and Evaluation Research (CBER) under ISO/IEC 17025 in the fields of biological and chemical testing. The ISO/IEC 17025 is a standard developed by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) to merge requirements for technical competence in testing and calibration laboratories with requirements for quality systems.

Oct 25   Texas DSHS Orders Sangar Fresh Cut Produce to Close, Recall Products.   The Texas Department of State Health Services today ordered Sangar Fresh Cut Produce in San Antonio to stop processing food and recall all products shipped from the plant since January. The order was issued after laboratory tests of chopped celery from the plant indicated the presence of Listeria monocytogenes, a bacterium that can cause severe illness.

Oct 21    Alert – Manufacturers of Drugs and Dietary Supplements – FDA Detects High Levels of Peroxide in Crospovidone.  The Agency recently detected excessive levels of peroxide in one lot of Crospovidone (cross linked polyvinyl N-pyrrolidone) manufactured by China-based Tianjin Boai NKY International Ltd¹.  The peroxide level found by the FDA in the lot was more than four (4) times the maximum level of peroxide (400 ppm) allowed by global compendial monographs.  Crospovidone is a very common ingredient in drugs and dietary supplements. Peroxide is a potential impurity from the polymerization step involved in the manufacturing of Povidone analogs. Residual peroxide levels of <100 ppm have been reported to cause oxidative degradation². The FDA is concerned that drug manufacturers using excipients containing high levels of peroxides will observe a loss of drug potency and the formation of excessive impurities during the product shelf life.   It is essential that users and distributors implement robust supplier management programs to assure that peroxide levels in Povidone analogs are in control for each batch received. Manufacturers using such excipients should employ sound risk management principles in establishing appropriate scrutiny (including peroxide testing regimen) and actions to take for a given supplier, including but not limited to the following:                                           (a) review supplier history, including any relevant information on manufacturing reliability;

(b) assess peroxide levels obtained from testing³ of past batches of Povidone analogs;  

(c) determine reliability of results reported on Certificates of Analysis;

(d) consider information obtained from ongoing communications with suppliers; and

(e) determine whether the quality of any finished product has been impacted.                                 Manufacturers who use ingredients that might contain elevated levels of peroxide are advised to notify the FDA if they become aware of any further findings of quality problems or potentially related adverse events.

--------------

               ¹ May also do business as Friends Union Enterprise (Jianjin) Ltd, Boai New Kaiyuan Pharmaceutical Company, Boai NKY Pharmaceuticals Ltd or Bluetech Chemicals Limited.

                     ²   Hartauer, et al, Pharm. Dev. Technol. 2000;5(3):303-10. “Influence of peroxide impurities in povidone and crospovidone on the stability of raloxifene hydrochloride in tablets: identification and control of an oxidative degradation product.”

³  A peroxide test is not currently listed in the USP monographs for crospovidone and povidone. However, a non-specific USP/EP method (see Copovidone NF) can be used to readily detect peroxide present at 400 ppm in Povidone analogs. Alternatively, a validated method shown to be specific for peroxide and having at least the same sensitivity as the compendial method may be used.  

Oct 15    FDA Approves Botox To Treat Chronic Migrane.   The U.S. Food and Drug Administration today approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month. To treat chronic migraines, Botox is given approximately every 12 weeks as multiple injections around the head and neck to try to dull future headache symptoms. Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month, or for other forms of headache. It is important that patients discuss with their physician whether Botox is appropriate for them.  The most common adverse reactions reported by patients being treated for chronic migraine were neck pain and headache.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229782.htm

Oct 14   FDA Tightens Reins on Unapproved “Chelation” Drugs.  FDA says consumers should avoid non-prescription products offered for chelation or detoxification. FDA-approved chelating agents are available by prescription only and are approved for use in specific indications such as the treatment of lead poisoning and iron overload. The agency says even the prescription medications carry significant risks, and they should only be used with medical supervision.  The products come in a number of forms, including sprays, suppositories, capsules, liquid drops, and clay baths.  A list of the firms that received the letters (along with the chelation products they market) can be found at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm229358.htm

Oct 14    Public Workshop “Safe Use Initiative” November 16-17, 2010.   The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is announcing a public workshop entitled “Safe Use Initiative.”  This one-and-one-half-day public workshop, organized and hosted by FDA’s Safe Use Initiative Team, will communicate the status of ongoing activities and future vision for Safe Use Initiative projects.  The workshop will also offer an opportunity for the Safe Use Initiative Team to gather input and perspectives for future directions and develop collaborative, cross-sector safe medication use activities with healthcare stakeholders.  It will provide a forum to engage the healthcare community about collaborations, interventions, and metrics for ongoing and future projects to make medications safer.  CDER is soliciting in advance of the public workshop topics for potential Safe Use collaborations. FDA will consider all topics; however, if submitted by October 15, 2010, some topics may become the focus for more in-depth discussions and partnership development during the public workshop.   Date(s):     November 16-17, 2010                                                             Location:    FDA White Oak Complex 
                   10903 New Hampshire Avenue
                   Bldg. 31, Room 1503
                   Silver Spring, Maryland 20993–0002

Oct 13   Possible Fracture Risk With Osteoporosis Drugs.  The Food and Drug Administration (FDA) is warning there is a possible risk of a rare type of thigh bone (femoral) fracture in people who take drugs known as bisphosphonates to treat osteoporosis.  The agency warned patients and health care professionals of this risk on Oct. 13, 2010, because the rare type of femoral fracture has been predominantly reported in patients taking these prescription medications.   Oral medications covered under this warning are: Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D, and their generic products.  Injectable products covered are Boniva, Reclast and their generic products.  More information at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm229127.htm

Oct 8      Oncology Drug Update

·         Pfizer Inc., in agreement with the FDA, announced that the commercial marketing of Mylotarg (gemtuzumab ozogamicin) will be voluntarily discontinued, and the new drug application (NDA) for Mylotarg will be withdrawn as of October 15, 2010.

·         FDA granted accelerated approval to nilotinib (Tasigna Capsules, Novartis Pharmaceuticals Corporation), an orally administered kinase inhibitor, for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP-CML).

·         FDA approved cabazitaxel (Jevtana Injection, sanofi-aventis) for use in combination with prednisone for treatment of patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen.

·         FDA approved hexaminolevulinate hydrochloride (Cysview for Intravesical Solution, Photocure ASA), as an optical imaging agent for use in combination with the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.  

·          FDA approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.  

·          FDA has been informed by Lundbeck, Inc., the sole worldwide manufacturer of Mustargen (mechlorethamine HCl for injection), that there will be an extended supply shortage of this drug.

·         FDA granted approval to rituximab (Rituxan, Genentech), in combination with fludarabine and cyclophosphamide (FC), for the treatment of previously untreated and previously treated patients with chronic lymphocytic leukemia (CLL).

·         FDA approved a risk evaluation and mitigation strategy (REMS) to ensure the safe use of Erythropoiesis-Stimulating Agents (ESAs).  The medications included in the program are marketed by Amgen under the names Aranesp (darbepoetin alfa) and Epogen (epoetin alfa) and by Centocor Ortho Biotech Products under the name Procrit (epoetin alfa).  FDA required Amgen, the manufacturer of these products, to develop the REMS based on studies demonstrating that use of ESAs can increase the risk of tumor growth and shorten survival in patients with cancer.

·         FDA granted accelerated approval to Tykerb (lapatinib) tablets for use in combination with letrozole tablets for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.

Oct 8      Slimming Beauty Bitter Orange Capsules – Undeclared Drug Ingredient.  FDA notified consumers that Slimming Beauty Bitter Orange Slimming Capsules contain the active pharmaceutical ingredient sibutramine, a prescription-only drug which is a stimulant. Sibutramine is not listed on the product label and could harm consumers, especially those with cardiovascular conditions, because it can lead to elevated blood pressure, stroke, and heart attack. Consumers who are otherwise healthy and who take the amount of sibutramine found in Slimming Beauty capsules can experience anxiety, nausea, heart palpitations, a racing heart, insomnia, and elevated blood pressure. Sibutramine also may interact with other medications and can cause serious side effects. Slimming Beauty is being sold over the Internet by Beautiful Health Inc., formerly LL Health and Beauty. Slimming Beauty sample packets also have been distributed by individuals at community events.

 Oct 8      Abbott Laboratories Agrees to Withdraw its Obesity Drug Meridia.  Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.  “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.”  Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

Oct 8     HHS Announces A Major New Investment In Community Health Centers.  HHS today announced awards of $727 million to 143 community health centers across the country to address pressing construction and renovation needs and expand access to quality health care.  The funds are the first in a series of awards that will be made available to community health centers under the Affordable Care Act.  The Capital Development (CD) program grants, administered by HHS’ Health Resources and Services Administration (HRSA), will support major construction and renovation at 143 community health centers nationwide.  This builds on the more than $2 billion investment in community health centers in the American Recovery and Reinvestment Act. A state by state list of Recovery Act investments in community health centers is available at http://www.hhs.gov/recovery/programs/hrsa/index.html .

Oct 8     Gaspari Nutrition Nutrition Issues a Voluntary Nationwide Recall of Novedex XT, a Product Marketed as a Dietary Supplement Containing ATD.   Gaspari Nutrition Incorporated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced today that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase. Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.  More info at:  http://www.fda.gov/Safety/Recalls/ucm228749.htm

Oct 7      New and Generic Drug Approvals.  The U.S. Food and Drug Administration has approved losartan potassium tablets as well as losartan potassium with hydrochlorothiazide tablets today.  Nine companies will be marketing Losartan and/or the combination product.

Oct 6     FDA awards $904,000 to Pan American Health Organization for Information “Hub”.   The U.S. Food and Drug Administration today announced the award of a $904,000 cooperative agreement to the Pan American Health Organization (PAHO) to research and develop an information hub for medical products and related regulatory processes and systems in the Americas Region.  The award will help FDA, and all PAHO member states, to better understand other countries' regulatory systems, support capacity to use harmonized standards and guidelines across countries, and prevent, and if necessary respond more quickly to, problems in the medical product supply chain. The “hub” will collect and produce data and map structures and processes in the areas of medical products, including drugs, biologics, vaccines, medical devices and other medical products, and related regulatory processes and systems.   Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm228423.htm

 Oct 4     FDA Awards Nearly $3 Million for TB.  The U.S. Food and Drug Administration today announced the award of $2.9 million to support six research projects that will help with the diagnosis, treatment, and prevention of tuberculosis (TB).   TB remains a major public health challenge with an increasing prevalence worldwide. Two recent articles published by FDA’s Office of Critical Path Programs note that advances are urgently needed in TB drug development to shorten therapy and to treat drug-resistant disease.  “FDA recognized an urgent need for the engagement and leadership of public health institutions to promote this critical, but neglected, area of medical therapeutics,” said FDA Commissioner Margaret A. Hamburg, M.D.  Read more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm228250.htm

Oct 4     Nearly 1,000 additional employers and unions will receive help providing health coverage to early retirees and their families.   The U.S. Department of Health and Human Services (HHS) today announced additional employers and unions accepted into the Early Retiree Reinsurance Program. Nearly 1,000 large and small businesses, State and local governments, educational institutions, non-profit organizations, and unions have been accepted into the program and will begin to, receive reimbursements for their early retirees’ medical claims this fall. The approvals announced today bring the total number of approvals to nearly 3,000 organizations. HHS announced the first round of nearly 2,000 approvals in August.  Details at:  http://www.hhs.gov/news/press/2010pres/10/20101004a.html

Oct 1     Miracle Mineral Solution (also known as Miracle Mineral Supplement and MMS) Turns Into Potent Bleach.   Consumers are being warned not to drink a product sold on the Internet as a medical treatment after some users got sick after drinking it—including one person who had a life threatening reaction.  The Food and Drug Administration (FDA) says the product—known as Miracle Mineral Solution, Miracle Mineral Supplement, and MMS—becomes a potent chemical that’s used as a bleach when mixed according to package directions. The agency first warned consumers about the product in July, but federal regulators say it’s still available for sale on the Internet.  FDA says the product is sold by many independent distributors on several websites and through online auctions. Consumers should be alert when buying such an item on the Internet because the product’s labeling, colors, and logos may vary.  According to FDA experts, drinking the amount recommended on product labels can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. Some labels claim vomiting and diarrhea are not uncommon after the product is ingested—and even maintain such reactions are evidence MMS is working.  FDA experts say MMS is dangerous, and they’re advising consumers to stop using the product immediately.

 Oct 1      Affordable Care Act gives consumers new tools, makes health insurance market more transparent.  The U.S. Department of Health and Human Services (HHS) today announced that new information and tools have been added to HHS' consumer website www.HealthCare.gov that will make the health insurance market more transparent, increase competition and help lower costs for individuals.  For the first time ever, price estimates for private insurance policies are available, allowing consumers to easily compare health insurance plans – putting consumers, not their insurance companies, in charge by providing one-stop shopping and taking the guesswork and confusion out of buying insurance.  To help consumers make more informed choices, the site includes new information including two notable metrics never before made public: 

·               Insurance providers are required to provide the percentage of people who applied for insurance and were denied coverage.

·               Insurance companies are required to provide the percentage of applicants who were charged higher premiums because of their health status.

Created under the Affordable Care Act, www.HealthCare.gov was launched July 1, 2010, and is the first website of its kind to bring information and links to health insurance plans into one place to make it easy for consumers to learn about and compare their insurance choices.  HHS’ Office of Consumer Information and Insurance Oversight (OCIIO) worked to define and collect detailed benefits and premium rating information from insurers across the country, and starting October 1, 2010, consumers will also be able to find information about health insurance options such as:

·               Monthly premium estimates;

·               Cost-sharing information, including annual deductibles and out-of-pocket limits;

·               Major categories of services covered;

·               Consumer’s share of cost for these services;

·               Percent of people in the plan who pay more than the base premium estimate due to their health Percent of people denied status; and

·               coverage from a health plan.

Aug 31   CDER's Small Business Assistance program has launched its new website:                                                                                       www.fda.gov/smallbusinessdrugs.                                                        Small pharmaceutical business is integral in bringing innovative medical products to the U.S.                  marketplace. The purpose of this website is to support the CDER Small Business Assistance Program’s     mission of promoting productive interaction with regulated industry by assisting regulated domestic and     international small pharmaceutical business seeking timely and accurate information relating to         development and regulation of human drug products.           

Aug 31   Availability of grant funds for the support of FDA’s Office of Orphan Products Development                 (OPD) grant program.   FDA is announcing the availability of grant funds for the support of FDA’s            Office of Orphan Products Development (OPD) grant program. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the estimated prevalence of the orphan disease or condition (or in the case of a vaccine or diagnostic, information to support the estimates of how many people will be administered the diagnostic or vaccine annually) and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.  Important dates are as follows:                                                                                                       1. The application due dates are February 2, 2011; February 1, 2012. The resubmission due dates are    October 14, 2011; October 15, 2012.
2. The anticipated start dates are November 2011; November 2012.
3. The opening date is December 2, 2010.
4. The expiration date is February 2, 2012; October 16, 2012 (resubmission).                                                               You may find additional information at:
http://edocket.access.gpo.gov/2010/pdf/2010-19354.pdf

Aug 31   Food and Drug Administration Announces Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop on November 4, 2010 and November 5, 2010.  The Small Business Assistance (SBA) program in the Center for Drug Evaluation and Research (CDER) provides guidance and information to regulated domestic and international small pharmaceutical business through its website, email notifications, and workshops. More information at its website: http://www.fda.gov/smallbusinessdrugs under Workshops.

Aug 31   Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions:   Annex 11 Capillary Electrophoresis General Chapter.  It can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194492.pdf

Aug 31   Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions:   Annex 12 Analytical Sieving General Chapter. It can be downloaded at:                 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194501.pdf 

Aug 31   Tygacil (tigecycline): Label Change - Increased Mortality Risk   FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.   

Aug 30   Guidance for Industry: Individual Product Bioequivalence Recommendations (26 Newly Added Recommendations; 10 Revised Recommendations).   This pdf file can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf   Individual Product bioequivalence Recommendations can be viewed at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm     

Aug 30   BARDA Funds Drug Development for Biothreats and Antibiotic Resistance.   The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) today awarded a contract to develop an antibiotic that could be used against possible two types of bioterrorism as well as common infections that are becoming resistant to antibiotics.  The contract to Achaogen Inc. of San Francisco is for $27 million in the first two years. The contract can be extended annually for up to three years for a total of $64 million.  The planned antibiotic, ACHN-490, would be a broad-spectrum antibiotic to treat plague and tularemia infections, both of which are possible bioterrorism agents. The antibiotic also could treat many infections that are becoming resistant to antibiotics.  Learn more at:  http://www.hhs.gov/news/press/2010pres/08/20100830a.html

Aug 26   Guidance for Industry:  Acute Bacterial Skin and Skin Structure Infections – Developing Drugs for Treatment.   This can be downloaded from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071185.pdf

Aug 25   FDA Warns Consumers to Avoid “TimeOut” Capsules.  The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure.  The product is marketed as a dietary supplement for sexual enhancement.  The FDA analyzed TimeOut and determined that it contains hydroxythiohomosildenafil, a chemical similar to sildenafil, the active ingredient in Viagra. Like sildenafil, this chemical may interact with prescription drugs such as nitrates, including nitroglycerin, and cause dangerously low blood pressure. When blood pressure drops suddenly, the brain is deprived of an adequate blood supply which can lead to dizziness or lightheadedness.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm224065.htm

Aug 24   New Insurance Finder Web Tool Simplifies the Process of Searching for Health Coverage.

The U.S. Department of Health and Human Services (HHS) today announced the release of  a new HealthCare.gov web tool available for download that makes searching for coverage options even easier than before.  The Insurance Finder “widget” enables anyone with a website or blog to embed a tool on their site allowing users to begin the process of searching for coverage options. The tool asks users two initial questions: “select a state” and “which best describes you.” Users then click on “next steps,” and are redirected to a page on HealthCare.gov that continues with the insurance finder process based on answers to their specific questions.  To view the widget and the embed code, visit this page: http://www.healthcare.gov/stay_connected.html

Aug 23   Public Workshop: Medical Device User Fee Program Public Meeting, September 14, 2010.  The purpose of the workshop is to provide an opportunity for stakeholders to present their views on the medical device user fee program. We welcome this opportunity to hear from stakeholders as we begin the next reauthorization process.  For date, time, location, background, agenda and other details go to: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm218250.htm

Aug 20  Miracle Mineral Solution: Dangerous to Drink.  Miracle Mineral Solution, also known as "Miracle Mineral Supplement" or "MMS," should not be consumed.  MMS is distributed on Internet sites and online auctions. MMS claims to treat HIV, hepatitis, the H1N1 flu, common colds, acne, cancer, and other conditions. FDA is not aware of any research showing that MMS is effective in treating any of these conditions.   The risk: When mixed with citrus juice or other acid as directed, the mixture produces a bleach used for stripping textiles and industrial water treatment. High doses of this bleach—such as those recommended on the label—can cause nausea, vomiting, diarrhea, and severe dehydration.  Announcement at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm221628.htm#MMS

Aug 19  FDA Announces Prescription Drug User Fees for Fiscal Year 2011.   FDA has announced the rates for prescription drug user fees for fiscal year (FY) 2011. The new Federal Register notice establishes fee rates for FY 2011 for application fees for an application requiring clinical data ($1,542,000), for an application not requiring clinical data or a supplement requiring clinical data ($771,000), for establishment fees ($497,200), and for product fees ($86,520). These fees are effective on October 1, 2010, and will remain in effect through September 30, 2011. For applications and supplements that are submitted on or after October 1, 2010, the new fee schedule must be used.

You may find additional information at:

http://edocket.access.gpo.gov/2010/pdf/2010-19116.pdf

Aug 16   FDA Proposes Withdrawal of Low Blood Pressure Drug   Companies failed to provide evidence of clinical benefit of midodrine hydrochloride.  The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.  Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.  The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

               To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.

 Aug 10    WHO Declares End to 2009 H1N1 Influenza Pandemic.  On August 10, 2010, the World Health Organization (WHO) International Health Regulations (IHR) Emergency Committee and the WHO Director-General, Dr. Margaret Chan, declared an end to the 2009 H1N1 influenza pandemic. This declaration was based on strong indications that influenza, worldwide, is transitioning toward seasonal patterns of transmission.  In the majority of countries, out-of-season 2009 H1N1 outbreaks are no longer being observed, and the intensity of 2009 H1N1 influenza virus transmission is lower than that reported during 2009 and early 2010. Members of the Emergency Committee further noted that the 2009 H1N1 viruses will likely continue to circulate for some years to come, taking on the behavior of a seasonal influenza virus.  This does not mean that the H1N1 virus has disappeared.  Rather, it means current influenza outbreaks including those primarily caused by the 2009 H1N1 virus show an intensity similar to that seen during seasonal epidemics. Pandemics, like the viruses that cause them, are unpredictable.  WHO noted that continued vigilance is extremely important, and it is likely that the virus will continue to cause serious disease in younger age groups and pregnant women, at least in the immediate post-pandemic period.  The WHO Director-General ended the Public Health Emergency of International Concern in accordance with the International Health Regulations (2005). More information about the WHO declaration is available on the WHO website at http://www.who.int/mediacentre/news/statements/2010/h1n1_vpc_20100810/en/index.html.

               Implications for United States:  This is a formal WHO declaration regarding the end of the pandemic at the global level. The U.S. Public Health Emergency determination for 2009 H1N1 Influenza expired on June 23, 2010.

 Aug 10   Prescription Drug Cost Relief to More Than 750,000 Medicare Beneficiaries.  Affordable Care Act Offers One-Time, $250 Rebate Checks for Eligible Medicare Beneficiariesin the Medicare Part D Donut Hole.  Today, the U.S. Department of Health and Human Services announced that the third round of one-time, tax-free $250 rebate checks have been mailed to eligible Medicare beneficiaries whose drug costs are so high they have reached the Medicare Part D prescription drug coverage gap known as the “donut hole.” Experts estimate that more than a quarter of Part D enrollees hit the donut hole and often stop following their drug regimen as a result of the added cost burden.  The $250 rebates will go a long way in preventing seniors from having to make such difficult and almost certainly harmful health decisions.  Across the country, more than 750,000 Medicare beneficiaries have already received checks this year, and more beneficiaries will be receiving checks in the coming months as they enter the coverage gap.  In 2011, the Affordable Care Act takes an additional step for Medicare beneficiaries in the donut hole by providing them with a 50 percent discount on their brand name medications.  Every year from 2011 to 2020, the Affordable Care Act will take progressive steps to close the donut hole. 

Aug 10   CDER's Small Business Assistance Educational Forum: The Investigational New Drug (IND) Process; Public Workshop October 8, 2010.  The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug (IND) Process and key aspects related to rare disease drug development and clinical trials.  The meeting will be held on October 8, 2010, beginning at 9:15 a.m., at the following location:  National Labor College (NLC),  George Meany Campus, 10,000 New Hampshire Ave.,  Silver Spring, Maryland 20903  (301) 431-6400  The meeting will not be videotaped or webcast.   More details at:  http://www.fda.gov/Drugs/NewsEvents/ucm221605.htm

Aug 5    CDER Ombudsman

The CDER Ombudsman receives and investigates complaints from CDER-regulated industry, law firms, health care providers, and consumers, and informally resolves disputes between those entities and CDER. The Ombudsman advises CDER management about Center program issues. Also, the Ombudsman can assist with resolution of scientific differences of opinion amongst CDER staff. The Ombudsman performs these duties while adhering to the ombudsman principles of ensuring confidentiality, neutrality, and informality.

The Ombudsman makes every effort to respond to all complaints in a timely and effective manner. Upon request, communications with the Ombudsman will be considered confidential.

 Aug 5    AAPS Workshop on Advances and Opportunities in Drug Product Manufacturing, September 20 - 21, 2010, Sheraton Inner Harbor Hotel, Baltimore, MD.   With the establishment of the new Manufacturing Science and Engineering section at AAPS, an annual two to three day themed conference devoted to various aspects of pharmaceutical /biotechnology manufacturing, packaging, engineering and quality is envisioned to be held every year. The conference in 2010 is the first in the series and will be focused on reviewing advances and opportunities in drug product manufacturing with a special focus on continuous manufacturing. While drug product manufacturing has been discussed in various workshops/conferences they have not focused on examples and practical applications of continuous manufacturing, advances in process control, and various approaches for managing risks to product quality throughout the product life cycle. On Day One, the meeting envisions providing a holistic perspective on continuous manufacturing in the pharmaceutical industry, which includes talks from academic, industry and regulatory bodies. The objective of Day Two is to provide an insight into some current approaches for quality risk management during manufacturing which includes adaptation of new techniques for process monitoring and product release as well as implementation of Continuous Verification throughout the product life cycle. Due to the vast field of manufacturing activity, this first conference will address only small molecule drug product manufacturing. A similar conference on biotech manufacturing will be the subject of a future MSE conference.  More at:  http://www.aapspharmaceutica.com/meetings/workshops/DPM/index.asp

 Aug 4     The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for     medical device user fees for fiscal year (FY) 2011.

               Medical Device Fees for FY 2011:

----------------------------------------------------------------------------------------------------------------------------

                                                                                            Standard Fee, as a

                                                                                        Percent of the Standard      FY2011              FY 2011 Small

               Application Fee Type                                         Fee for a Premarket         Standard Fee      Business Fee

                                                                                                 Application

               -----------------------------------------------------------------------------------------------------------------------------

               Premarket application (a PMA submitted under      Set in Statute              $236,298             $59,075

               section 515(c)(1) of the act (21 U.S.C.

               360e(c)(1)), a PDP submitted under section

               515(f) of the act, or a BLA submitted under

               section 351 of the Public Health Service

               (PHS) Act (42 U.S.C. 262))

               -----------------------------------------------------------------------------------------------------------------------------

               Premarket report (submitted under section                         100%              $236,298             $59,075

               515(c)(2) of the act)

               -----------------------------------------------------------------------------------------------------------------------------

               Efficacy supplement (to an approved BLA under              100%              $236,298              $59,075

               section 351 of the PHS Act)

               -----------------------------------------------------------------------------------------------------------------------------

               Panel-track supplement                                                       &n, bsp; 75%              $177,224             $44,306

               -----------------------------------------------------------------------------------------------------------------------------

               180-day supplement                                                               15%                $35,445               $8,861

               -----------------------------------------------------------------------------------------------------------------------------

               Real-time supplement                                                              7%

Aug 3     Guidance for Industry:  Label Comprehension Studies for Nonprescription Drug Products.   This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM143834.pdf

July 27   New Address for ANDA submissions.   FDA is amending 21 CFR 314.440(a)(2) to update the address for applicants to submit ANDAs and ANDA amendments, supplements, and resubmissions. FDA is also amending 21 CFR 312.140(a)(1) to update the address for ANDA applicants to submit INDs for in vivo bioavailability and bioequivalence studies that are intended to support ANDAs. The new address for all these submissions is: Office of Generic Drugs (HFD–600)                                                                                                             Center for Drug Evaluation and Research                                                                                                             Food and Drug Administration                                                                                                                Metro Park North VII                                                                                                                             7620 Standish Pl.                                                                                                                                          Rockville, MD 20855                                                                               This rule is effective August 1, 2010.  You may find additional information at: http://edocket.access.gpo.gov/2010/pdf/2010-15711.pdf

July 27  Rite Aid Agrees to Pay $1 Million to Settle HIPAA Privacy Case.  Rite Aid Corporation and its 40 affiliated entities (RAC) have agreed to pay $1 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, the U.S. Department of Health and Human Services (HHS) announced today. In a coordinated action, RAC also signed a consent order with the Federal Trade Commission (FTC) to settle potential violations of the FTC Act.

Rite Aid, one of the nation’s largest drug store chains, has also agreed to take corrective action to improve policies and procedures to safeguard the privacy of its customers when disposing of identifying information on pill bottle labels and other health information. The settlements apply to all of Rite Aid’s nearly 4,800 retail pharmacies and follow an extensive joint investigation by the HHS Office for Civil Rights (OCR) and the FTC.  These incidents were reported as occurring in a variety of cities across the United States.  Rite Aid pharmacy stores in several of the cities were highlighted in media reports.  Disposing of individuals’ health information in an industrial trash container accessible to unauthorized persons is not compliant with several requirements of the HIPAA Privacy Rule and exposes the individuals’ information to the risk of identity theft and other crimes.  This is the second joint investigation and settlement conducted by OCR and FTC. OCR and FTC settled a similar case involving another national drug store chain in February 2009.

July 22  Federal Government Seizes Cyanide Antidote Kits from California Company.  FDA says Keystone kits are unapproved new drugs, and have not been proven safe and effective.  At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California.  Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe.  Most commonly, cyanide exposure occurs through inhaling smoke in residential fires, or through inhaling cyanide fumes during industrial accidents.  The cyanide antidote kits distributed by Keystone are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use. 

July 19   ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents   FDA has issued a draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents.   It can be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM219492.pdf 

July 21   FDA Issues recall on Motrin IB (Ibuprofen) Caplets USP manufactured at McNeil Healthcare’s  Las Piedras, Puerto Rico Facility  Recall of lot #SDA149 (Expiry Date 10/2010) of bottles of 24 coated caplets of Motrin IB (Ibuprofen) Caplets USP, 200mg was issued because product failed dissolution specification.  This comes on the heels of a recall of 21 lots of over-the-counter medicines. The lots involved are sold in the United States, Fiji, Guatemala, Dominican Republic, Puerto Rico, Trinidad & Tobago, and Jamaica. This action is a follow-up to a product recall that McNeil Consumer Healthcare originally announced on January 15, 2010, which was initiated following consumer complaints of a musty or moldy odor, which has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA).   Various Benadryl, Tylenol, and Motrin products are involved.

July 8     Using Quinine Sulfate for Nighttime Leg Cramps Is Risky.  People who use the drug Qualaquin to treat or prevent nighttime leg cramps may be at risk for serious and life-threatening reactions, according to the Food and Drug Administration (FDA).    Qualaquin (quinine sulfate) is FDA-approved only to treat a certain type of malaria (uncomplicated malaria) caused by the parasite Plasmodium falciparum. This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs.  However, most of Qualaquin’s use in the U.S. is for the treatment or prevention of nighttime leg cramps—a use not approved by FDA.  FDA has received reports of side effects after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. Side effects included serious and life-threatening reactions in 38 reports.  Of these 38 reports, there were 24 blood-related reactions, including a severe lowering of platelets in the blood. Some of the blood-related side effects resulted in permanent kidney damage, hospitalization, and two deaths.  Although not mentioned in the FDA report, it has been proposed that in many cases dehydration is responsible for muscle cramps; the nighttime cramps can be minimized by simply drinking a full glass of water just before retiring for the night. 

July 8     More Seniors to Receive One-Time Donut Hole $250 Rebate Checks as a Result of the Affordable Care Act.  The next round of more than 300,000 eligible seniors who have entered the Medicare Part D “donut hole” this year have been mailed their tax-free, one time rebate check for $250.  The first round of checks were distributed in the middle of June. As qualifying Medicare recipients “fall into the donut hole,” they will be sent a rebate check by Medicare.  The donut hole is the period in the prescription drug benefit in which the beneficiary pays 100 percent of the cost of their drugs until they reach the catastrophic coverage phase.

July 6     After 2 Years CDERLearn is Back!  CDER's primary mission is to make certain that safe and effective drugs are available to the American people. There is, however, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process, the vital role health care professionals play to assist FDA in fulfilling its duties, and many other important issues. Online training is one way to share FDA expertise with many more people than face-to-face classroom sessions would allow, and we will offer additional CDER courses in the future.  Full information can be found at:   http://www.fda.gov/Training/ForHealthProfessionals/default.htm                                                                                The Course List:                                                                                                                                            The Past, Present, and Future of FDA Human Drug Regulation                                                          Medicines in my Home – An Interactive Home                                                                                   Bringing an Unapproved Drug into Compliance                                                                                  Risk Assessment and Communication                                                                                                 FDA Medwatch and Patient Safety                                                                                                                Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)                                                 The FDA Process for Approving Generic Drugs                                                                                             An Introduction to the Improved FDA Prescription Drug Labeling                                              

June 28  Bottled Water Everywhere – Keeping it Safe.  Consumers drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm203620.htm  

June 24  Guidance for Industry: CMC Post-approval Manufacturing Changes Reportable in Annual Reports    This guidance can be found as a PDF - 109KB at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf    

June 22 CDER Has Published a List of Key Officials.  The PDF file can be downloaded at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ContactCDER/UCM070722.pdf             

June 22   Magic Power Coffee – Potentially Dangerous, Not Magical!   Consumers should not use an instant coffee being sold online as a dietary supplement for sexual enhancement, warns the Food and Drug Administration (FDA).  The product, Magic Power Coffee, contains a potentially dangerous ingredient. The product is sold in a two-serving box as well as in a carton that contains six two-serving boxes.  The FDA’s lab analysis determined that Magic Power Coffee contains hydroxythiohomosildenafil, a chemical similar to the active ingredient in the prescription drug Viagra to treat erectile dysfunction. The chemical may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Although Magic Power Coffee is labeled as an “all natural dietary supplement,” it can cause serious harm. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death. 

June 22  FDA Warns About Fraudulent Tamiflu.  Fraudulent product is dangerous to patients allergic to penicillin.  The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as “Generic Tamiflu” sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu’s active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.  The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.  There is no FDA-approved generic drug for the prescription product Tamiflu.

 June 17  FDA Approves New Treatment for Advanced Prostate Cancer   The U.S. Food and Drug Administration today approved Jevtana (cabazitaxel), a chemotherapy drug used in combination with the steroid prednisone to treat men with prostate cancer. Jevtana is the first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.  In prostate cancer, the male sex hormone testosterone can cause prostate tumors to grow. Drugs, surgery, or other hormones are used to reduce testosterone production or to block it. Some men have hormone refractory prostate cancer, meaning the prostate cancer cells continue to grow, despite testosterone suppression. Different treatments are needed for men with this type of cancer.  Jevtana was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Jevtana received approval ahead of the product’s Sept. 30, 2010, goal date.  Side effects in those treated with Jevtana included decrease in infection-fighting white blood cells (neutropenia), anemia, decrease in the number of white blood cells (leukopenia), low level of platelets in the blood (thrombocytopenia), diarrhea, fatigue, nausea, vomiting, constipation, weakness (asthenia), and renal failure. 

June 16  Infant Overdose With Liquid Vitamin D   The Food and Drug Administration (FDA) is warning of the potential risk of overdosing infants with liquid vitamin D.  Some liquid vitamin D supplement products on the market come with droppers that could allow parents and caregivers to accidentally give harmful amounts of the vitamin to an infant. These droppers can hold a greater amount of liquid vitamin D than an infant should receive.  Excessive vitamin D can cause nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.  Infants should not receive more than 400 international units (IUs) of vitamin D a day, which is the daily dose of vitamin D supplement that the American Academy of Pediatrics recommends for breast-fed and partially breast-fed infants.  For more information and recommendations go to:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm214343.htm        

June 9    Public Workshop on Thursday, June 24, 2010 entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors”  The Food and Drug Administration (FDA) is announcing a public workshop entitled “Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors” to initiate dialogue and share information about the design of drug and therapeutic biologic container labels, carton labeling, and product packaging, and practices to develop testing of proprietary names to reduce medication errors.    It will be held at the Holiday Inn, 10000 Baltimore Ave., College Park, MD 20740 from 8:30am – 4:00pm on Thursday, June 24, 2010, and on Friday, June 25, 2010 from 8:30am – Noon.  Details at: http://www.fda.gov/Drugs/NewsEvents/ucm214703.htm

June 9    Access to Investigational New Drugs   Expanded access, sometimes called “compassionate use” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternate treatment options.  On Tuesday, February 23, at 3 p.m. ET, the FDA hosted a 30-minute webinar on Access to Investigational Drugs. The featured speakers, Theresa Toigo, Director, Office of Special Health Issues and Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues, discussed factors to consider in deciding whether to seek access to an investigational drug and the ways to access investigational drugs.  You can view the webinar by going to:  http://www.fda.gov/AboutFDA/Basics/ucm200769.htm

June 2    FDA Issues Final Guidance on Statement of Investigator (Form FDA 1572)   FDA has issued final information sheet guidance on "Frequently Asked Questions - Statement of Investigator (Form FDA1572)."   The Guidance is entitled, “Information Sheet Guidance for Sponsors, Clinical Investigators and IRBs, Frequently Asked Questions – Statement of Investigator (Form FDA 1572).  The document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf  

June 1   FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women   The U.S. Food and Drug Administration today approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.  More Info at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm214150.htm

May 26  FDA Announces Collaboration with Drugs.com   The goal is to expand online distribution of Agency’s consumer health information.  The U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access to the FDA’s consumer health information.  Drugs.com seeks to provide patients with information to better manage their own health care and to assist in the reduction of medication errors. It attracts more than 12 million unique visitors each month.

May 26  Weight-Loss Drugs and Risk of Liver Failure   People who take Xenical or Alli ne, ed to be aware of the rare occurrence of severe liver injury reported in some individuals who take these weight-loss drugs.  The active ingredient in both of these drugs is orlistat. Xenical (orlistat 120 mg) is a prescription product. Alli (orlistat 60 mg) is sold over-the-counter without a prescription.  What Consumers Should Do - contact your health care professional immediately if you experience itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.  Learn more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm213401.htm

May 24   No Evidence Linking Cell Phone Use to Risk of Brain Tumors   Do the radio waves that cell phones emit pose a threat to health?  Although research is ongoing, the Food and Drug Administration (FDA) says that available scientific evidence—including World Health Organization (WHO) findings released May 17, 2010—shows no increased health risk due to radiofrequency (RF) energy, a form of electromagnetic radiation that is emitted by cell phones.  FDA also cites a separate National Cancer Institute program finding that, despite the dramatic increase in cell phone use, occurrences of brain cancer did not increase between 1987 and 2005.  FDA shares regulatory responsibilities for cell phones with the Federal Communications Commission.  Although cell phones can be sold without FDA clearance or approval, the agency monitors the effects the phones have on health. FDA has the authority to take action if cell phones are shown to emit RF energy at a level that is hazardous to the user.  Although evidence shows little or no risk of brain tumors for most long-term users of cell phones, FDA says people who want to reduce their RF exposure can:                                                                                

·         reduce the amount of time spent on the cell phone

·         use speaker mode or a headset to place more distance between the head and the cell phone

May 12   Medication Errors from Swallowing Benadryl Extra Strength Itch Stopping Gel   The U.S. Food and Drug Administration (FDA) has received reports of adverse events in consumers who mistakenly swallowed Benadryl Extra Strength Itch Stopping Gel. Although there are over-the-counter liquid Benadryl products intended to be swallowed, Benadryl Extra Strength Itch Stopping Gel is a topical product that is used on the skin. Benadryl Extra Strength Itch Stopping Gel should NOT be swallowed.

Benadryl Extra Strength Itch Stopping Gel is safe and effective when used on the skin as directed. Swallowing it can result in people receiving dangerously large amounts of the active ingredient, diphenhydramine. This can result in serious adverse events, such as unconsciousness, hallucinations, and confusion.  To help consumers recognize that Benadryl Extra Strength Itch Stopping Gel is meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:

·         Changed the product label to add a new, prominent statement "For Skin Use Only."

·         Attached a sticker to the cap of the product that says "For Skin Use Only."

·         Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.                                       

FDA encourages manufacturers of similar products to follow Johnson and Johnson's example and adopt similar changes to their labeling and packaging.

May 12   Medical Costs of Cancer Have Nearly Doubled Over the Past Two Decades   A new analysis finds that the costs of treating cancer have nearly doubled over the past two decades and that the shares of these costs that are paid for by private health insurance and Medicaid have increased. The study also reveals that cancer costs have shifted away from inpatient treatments to outpatient care. Published early online in Cancer, a peer-reviewed journal of the American Cancer Society, the information could be used to prioritize future resources for treating and preventing cancer.  The analysis also revealed that the share of total cancer costs incurred after inpatient hospital admissions fell from 64.4 percent in 1987 to 27.5 percent in 2001–2005. The decrease in cancer-related inpatient costs was accompanied by an increase in cancer-attributable outpatient expenditures.

May 10  New CDC Study Finds Colorectal Cancer Screening Practices Need Improvement Current screening methods for fecal occult blood tests often are not appropriate.  More than 75% of primary care physicians in the United States who order or perform the fecal occult blood tests (FOBT) as a screening option for colorectal cancer perform an in-office test rather than relying on the home-based test, even though the home-based test is more accurate, a study by the Centers for Disease Control and Prevention (CDC) has found.  National guidelines recommend that FOBT testing be done with stool samples collected at home. Previous studies have shown that the in-office FOBT, in which a single stool sample is collected by a physician during a digital rectal examination, is ineffective because it misses 95% of cancers or polyps that may become cancer. The in-office test is not recommended for colorectal cancer screening.

May 4   Compliance Program Guidance Manual: 7346.832, Pre-Approval Inspections/Investigations   This information has been updated.  You can download a copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071871.pdf                                               

May 1    McNeil Recalls Infant and Children’s Liquid Products   Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and children’s liquid products due to manufacturing deficiencies which may affect quality, purity or potency.  The products include certain liquid infant’s and children’s Tylenol®, Motrin®, Zyrtec®, and Benadryl® products.  McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. As a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. There are a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. FDA recommends that you check the labeling of these products. If you have any questions, you should discuss this with your pharmacist or other health care professional. FDA does not anticipate that there will be a shortage of alternative products. 

Apr 27   Pharmaceutical Giant Astrazeneca To Pay $520 Million    AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Departments of Justice and Health and Human Services’ Health Care Fraud Enforcement Action Team (HEAT) announced today. Such unapproved uses are also known as “off-label” uses because they are not included in the drug’s FDA approved product label.   Between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).  These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

Apr 19   New contact information for the CDER Small Business Assistance Program                                                     

Center for Drug Evaluation and Research, Office of Communications                                                    Division of Drug Information                                                                                                            Brenda Stodart PharmD                                                                                                                        Small Business Assistance                                                                                                                                     E-mail: CDERSmallBusiness@fda.hhs.gov                                                                                           10903 New Hampshire Avenue, RM 2286                                                                                                    Silver Spring, MD 20993                                     

                                                                            Phone - (301) 796-3400

Feb 28    CDC H1N1 Flu Website Situation Update FDA   Visits to doctors for influenza-like illness (ILI) nationally decreased this week over last week and remain low. Very few hospitalizations were reported by states during the week ending February 20.

Feb 26    OneTouch SureStep Test Strips (LifeScan) Recall. LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.  More information at:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm202254.htm

Feb 1      New Guidance for Industry:                                                                                                                                                                    

•1.      Draft - Adaptive Design Clinical Trials for Drugs and Biologics.   PDF - 424 KB at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf

•2.      Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes.  PDF - 69 KB at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072180.pdf

•3.      Individual Bioequivalence Guidance for Various Drugs.  More at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm

Feb 24    Good Clinical Practice/Human Subject Protection Update.  The Food and Drug Administration is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data involving studies including, but not limited to, clinical investigators, nonclinical laboratory studies, and clinical studies in animals. The proposed rule is now available using the following web link: http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf  Comments to this proposed rule are due by May 20, 2010.

Feb 24    Warning Letter Close-out Letter for Warning Letters Issued After September 1, 2009.  The FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter.  More info at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Feb 23    Reporting Problems to FDA (video).   View this video to learn how to submit reports of problems to FDA and how the agency uses this information:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm201375.htm  

Feb 22    Orange Book:  The latest version may be found at:  http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

              Orange Book: January 2010: Additions and Deletions to the Drug Product List may be found at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM201486.pdf 

              Current Cumulative Supplement.  PDF - 333KB at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM201486.pdf

Feb 20    Ear Candles: Risk of Serious Injuries.  FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer's directions. According to advertised claims, a burning ear candle draws ear wax and "impurities" or "toxins" out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearin, g, "blood purification," improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles. 

Feb 17    Product Confusion with Maalox Total Relief and Maalox Liquid Products   The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products. Maalox Total Relief and the traditional Maalox products are both liquid medications available without a prescription (OTC), but are NOT interchangeable.  These products are intended to treat different medical conditions.

Feb 11    FDA Data Standards Update - SPL Terminology & SPL Starter Package Updates.  The FDA has received numerous complaints concerning their user unfriendly software for registration and listing of drug products.  Requests for a waiver to submit registration and listing on paper are denied unless the company has no access to the internet whatsoever.  Many companies are using electronic content management service companies such as Reed Technology and Information Services, Inc. (http://www.reedtech.com/ ) as a low cost alternative to using their own company staff to file registration and listing information.

The FDA has recently updated their SPL Starter Package: SPL Starter Package 1.4 - (copy and paste into your address bar): http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm

Feb 2      FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain.   The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm198667.htm

Feb 2      Drug Shortages

•·        Acyclovir    Teva Pharmaceuticals has had manufacturing delays and is planning the following dates for availability:  The 800 mg tablets are planned to be released the week of 2/15.
The 600 mg tablets are planned to be available in early March and the 200mg tablets in early April.
The acyclovir capsules are anticipated to be available soon as well.

•·        Erythromycin Ophthalmic Ointment          Bausch & Lomb is experiencing an increase in demand for this product; they are producing it at a rate consistent with historical use data. 

Feb 1      Key Flu Indicators.  Visits to doctors for influenza-like illness nationally are low.  Overall cumulative hospitalization rates for the 2009-10 influenza season have leveled off in all age groups and very few 2009 H1N1-laboratory confirmed hospitalizations were reported by states during the week ending January 23.  No states reported widespread influenza activity.  Almost all of the influenza viruses identified so far continue to be 2009 H1N1 influenza A viruses and these remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

Jan 27    New Guidance.

•·        The Food and Drug Administration announced in a Federal Register notice of January 21, 2010, the availability of a guidance entitled ‘‘M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.''   The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. http://edocket.access.gpo.gov/2010/pdf/2010-1027.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

•·        The Food and Drug Administration announced in a Federal Register notice of January 27, 2010, the availability of a guidance for industry entitled ‘‘The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2-Current Good Manufacturing Practice (CGMP).'' This guidance recommends an alternative method for manufacturers to comply with FDA's CGMP regulations that require laboratory apparatus be calibrated at suitable intervals in accordance with established written specifications.  The guidance is intended to aid drug manufacturers (including ancillary testing laboratories) in calibrating U.S. Pharmacopeia (USP) Dissolution Apparatus 1 and 2 to help assure that critical parameters associated with the dissolution apparatus meet certain mechanical calibration (MC) tolerances. http://edocket.access.gpo.gov/2010/pdf/2010-1517.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198649.pdf

•·        The Food and Drug Administration announced in a Federal Register notice of January 27, 2010, the availability of a draft guidance for industry entitled ‘‘Assessment of Abuse Potential of Drugs.'' This draft guidance is intended to assist sponsors who are developing drug and other medical products with the potential for abuse that may need to be scheduled under the Controlled Substances Act. Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change. http://edocket.access.gpo.gov/2010/pdf/2010-1516.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM198650.pdf

Jan 27    Inactive Ingredient Data Base Updated. Database provides ability to search for inactive ingredients in approved drug products. http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

Jan 27    Drug Shortages Resolved: Morphine Sulfate Oral Solution  Roxane Laboratories has recently received FDA approval for Morphine Sulfate Oral solution 100mg    per 5ml (20 mg/ml). This is the only FDA approved morphine sulfate oral solution available at this concentration. The firm has sufficient supply to meet the entire market demand and no shortage is anticipated.  Morphine 20mg/5ml and 10mg/5ml remain available as approved products as well.  For the morphine 100mg per 5ml (20mg/ml), there will be a transition period to the new packaging, labeling, and NDC numbers.

Jan 25   Warning: Counterfeit Alli.  The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.  The counterfeit Alli has                                                           

•·         a missing LOT code on the outer cardboard packaging

•·         an expiration date that includes a MONTH, DAY, and YEAR-the expiration date of the real Alli only contains a MONTH and a YEAR

•·         a plain foil for the inner safety seal without any words on it-the safety seal of the real Alli has the words "SEALED FOR YOUR PROTECTION" prominently printed on it.

•·         large capsules with white powder, as opposed to small white pellets found in the real Alli

•·         a slightly taller plastic bottle with a wider cap and coarser ribbing on the cap than what is seen with the real Alli

Jan 20       New Guidance.  M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF - 295 KB).  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

Jan 15       McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji.   The company is initiating this recall following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea.   Based on this investigation, McNeil Consumer Healthcare has determined that the reported uncharacteristic smell is caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). This can result from the breakdown of a chemical that is sometimes applied to wood that is used to build wood pallets that transport and store product packaging materials.  Learn more at:  http://www.fda.gov/Safety/Recalls/ucm197746.htm

Jan 13       What Vaccines Do You Need (interactive)   More at:  http://www2a.cdc.gov/nip/adultImmSched/   

Jan 13       New Guidance   FDA has issued draft guidance on "IRB Continuing Review after Clinical Investigation Approval."  The guidance document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf.

Jan 11        FDA Approves New Drug for Rheumatoid Arthritis.   The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.  There is a risk for serious adverse side effects.  Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197108.htm   

Jan 7         Structured Product Labeling Training Sessions Announced.  The 2010 Winter/Spring SPL R4 training sessions SPL 101 and Advanced have been scheduled:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm.   

More training sessions will be scheduled in the future.  

Jan 6         Unique Device Identification Update.  The Global Harmonization Task Force (GHTF) has posted the GHTF Discussion Paper (in view of preparation of a draft guidance on) UDI for Medical Devices.  The title of the paper is "Unique Device Identification (UDI) System".  It can be found at http://www.ghtf.org/ahwg/ahwg-proposed.html   Comments can be sent to entr-cosm-med-dev@ec.europa.eu  .   The deadline for submitting comments is 31 March 2010. 

Dec 30     Information from CDER's Small Business Assistance Bulletin

1)  Newly Added Guidance Documents. This website provides newly added guidance documents issued within the last three months. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm 

                 2)  Orphan Drug Workshops. The FDA has scheduled a series of workshops about orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases. Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs. The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm195343.htm 

                  3)  FDA/DIA 5th Workshop in a Series on Pharmacogenomics: Generating and Weighing Evidence in Drug Development and Regulatory Decision Making, February 2-4, 2010, 5701 Marinelli Road, Bethesda, MD. More info at:  http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=21509&eventType=Meeting&rpex=N&evtyp=AMTG,MTG&kw=10005&sdt=11-12-2009 

•4)      DIA/FDA CDER/CBER Computational Science Annual Meeting, March 22-23, 2010, Bethesda, MD. Learn more at http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21575&eventType=Meeting  

Dec 30      FDA Warns Public of Continued Extortion Scam by FDA Impersonators.   The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam.  The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.                                                                         The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm, and or incarceration.  "Impersonating an FDA official is a violation of federal law," said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs. "The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment."                                                    FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action, with fines payable to the U.S. Treasury.                                                                                                                                                                                               Anyone receiving a telephone call from a person purporting to be an FDA or other law enforcement official who is seeking money to settle a law enforcement action for the illegal purchase of drugs over the Internet should refuse the demand and call the FDA's Office of Criminal Investigations Metro Washington Field Office at (800) 521-5783 to report the crime.

In addition to posing as FDA officials, criminals have posed as special agents of the DEA, FBI, U.S. Secret Service, U.S. Customs Service, as well as U.S. and Dominican prosecutors and judges. In response, the FDA, in conjunction with various federal, state, and local agencies, is actively pursing criminal charges.                                                                                                                                The FDA also reminds consumers to use caution when purchasing prescription drugs over the telephone or the Internet. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, there is the danger that personal data can be compromised. For more on FDA's concerns about unlawful drug sales on the Internet, see http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.   

Dec 23      Orphan Drug Workshops Scheduled For Feb. 25-26 and Aug. 3-4, 2010

As part of its continuing effort to make the agency more transparent and accessible, the FDA has scheduled a series of workshops abou, t orphan drug designation for academics, biotechnology companies, and those unfamiliar with the process. The FDA can grant a special status, known as orphan designation, for drug products intended to treat rare diseases.

Orphan drugs are either drug or biologic products used to treat conditions affecting fewer than 200,000 people in the United States. Orphan drugs may be already-approved or experimental drugs.

The workshops will be held Feb. 25-26, 2010, in Claremont, Calif., and Aug. 3-4, 2010, in Minneapolis. At the workshops, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. To help participants develop strong applications, FDA staff will provide one-on-one regulatory help.  For more information:

 FDA Orphan Drug Workshops

http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/UCM189586.pdf

Designating an Orphan Product: Drugs and Biologics

http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm

Dec 23    2009-2010 Influenza Season Week 50 ending December 19, 2009   During week 50 (December 13-19, 2009), influenza activity continued to decrease in the U.S.                                                                                                                                                      

•·         The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.

•·         Nine influenza-associated pediatric deaths were reported. Eight of these deaths were associated with 2009 influenza A (H1N1) virus infection and one was associated with an influenza A virus for which the subtype was undetermined.

Dec 22      Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions 

Annex 5: Disintegration Test General Chapter (PDF - 32 KB)  Obtain at       http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf     

Annex 8: Sterility Test General Chapter (PDF - 32 KB)  Obtain a copy at:      www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm085370.pdf

Dec 18      CDER LEARN Courses Now Being Offered  Learn more at: http://www.fda.gov/Training/ForHealthProfessionals/default.htm

•·         Bringing an Unapproved Drug Into Compliance
The primary audience for this course is manufacturers/distributors of drugs marketed without FDA approval or compliance with an OTC monograph. The secondary audience is health care providers and organizations that establish formularies. Course Time: Approximately 90 minutes

•·         Risk Assessment and Communication
This CME program offered through Discover Health explains ways that physicians can communicate risk to their patients to help them make informed health care decisions. Available for credit through June 27, 2011

•·         FDA Medwatch and Patient Safety
an online tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting

•·         Field Investigators: Adverse Drug Effects (ADE) Investigators (2000)

•·         The FDA Process for Approving Generic Drugs Credit is no longer available for this course.

•·         An Introduction to the Improved FDA Prescription Drug Labeling
The primary audience for this course content is physicians, physician assistants, pharmacists, nurses, nurse practitioners, and dentists. Secondary audiences include other health practitioners who are interested in the revised prescription drug labeling.

Dec 16      Recently issued Guidance for Industry:  Read at:  http://mail.google.com/mail/?shva=1#inbox/1259d539ff3a3fb1 

                  The Guidance are

1)  Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology -Derived Pharmaceuticals

2&3) Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

              Annex 11: Capillary Electrophoresis General Chapter

              Annex 12: Analytical Sieving General Chapter

Dec 16      Other Recently Issued Guidance

1)  Product-Specific Bioequivalence (BE) Recommendations. The Food and Drug Administration announced in a Federal Register notice of December 1, 2009, the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

http://edocket.access.gpo.gov/2009/pdf/E9-28593.pdf   and http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm  

2)  ‘‘Assay Development for Immunogenicity Testing of Therapeutic Proteins.'' The draft guidance provides recommendations to facilitate industry's development of immune assays for assessment of the immunogenicity of therapeutic proteins during clinical trials.

http://edocket.access.gpo.gov/2009/pdf/E9-28960.pdf   and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf  

3)  ‘‘Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> ‘‘Residual Solvents,'' which replaced USP General Chapter <467> ‘‘Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes

http://edocket.access.gpo.gov/2009/pdf/E9-28247.pdf   and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070621.pdf 

Dec 2        Comprehensive List of Guidance Documents for 2009 can be downloaded at: 

                  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079645.pdf  

Dec 2        New/Revised/Withdrawn List of Guidance Documents for 2009 can be downloaded at:

                  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079655.p

Nov 25     CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process; Public Workshop October 15, 2009.   The slides from the presentations at the above Workshop are attached. http://www.fda.gov/Drugs/NewsEvents/ucm182606.htm 

Nov 25      Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Production and Process Controls.   This information can be found at:   http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124782.htm 

Nov 25      New Guidance on Pharmaceutical Development.  This document can be downloaded at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf 

Nov 23            The FDA has announced the availability of a new Guidance for Industry:  Q8(R2) Pharmaceutical Development.  It can be found at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507

Nov 20            Vicks Sinex Nasal Spray - Recall   Procter & Gamble and FDA notified consumers of a voluntary recall of three lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom. The bacteria B. cepacia was found in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. Consumers should simply discard the affected product as they would any over the counter medicine. Customers who have the affected lots can call P&G for a replacement coupon or refund.

Nov 20            Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)   FDA Reviews Docket Submissions and Comments from Stakeholder and Public Meetings (Update - November 2009).  FDA is reviewing public and stakeholder input related to the development of a Risk Evaluation and Mitigation Strategy (REMS) for certain opioid drug products.  FDA formed an Opioid REMS Steering Committee, a multidisciplinary team from throughout the Center for Drug Evaluation and Research to carefully review and consider all the input we have received.  This work is divided among eight workgroups that will focus on the following key areas: scope, prescriber education, pharmacist education, patient education, pharmacy systems, patient access to pain medication, metrics and public communication.  FDA recently announced the re-opening of the opioid REMS comment period through October 19, 2010.  

Nov 20            CDC H1N1 (Swine Flu) situation update    Each week CDC analyzes information about influenza disease activity in the United States and publishes findings of key flu indicators in a report called FluView.  During the week of November 8-14, 2009, influenza activity decreased across all key indicators, but overall remained very high for this time of year.

Nov 19            Update of CVM's What's New - Guidance for Industry 191 - New NADAs vs. Category II Supplemental NADAs.  This can be found at: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052460.pdf

Nov 19            FDA Issues 22 Warning Letters to Web site Operators  Part of International Internet Week of Action  The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.  During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.  The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. "The FDA works in close collaboration with our regulatory and law enforcement counterparts in the United States and throughout the world to protect the public," said FDA Commissioner Margaret A. Hamburg, M.D. "Many U.S. consumers are being misled in the hopes of saving money by purchasing prescription drugs over the Internet from illegal pharmacies. Unfortunately, these drugs are often counterfeit, contaminated, or unapproved products, or contain an inconsistent amount of the active ingredient. Taking these drugs can pose a danger to consumers." 

Nov 17            FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.  Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review. It was approved on Nov. 16.   Learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm

Nov 13            FDA to Examine the Safety of Caffeinated Alcoholic Beverages.    On Nov. 13, 2009, the Food and Drug Administration (FDA) sent letters notifying nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.  "The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible," says Joshua Sharfstein, M.D., principal deputy commissioner of food and drugs.  To date, FDA has approved caffeine only as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. The agency has not approved caffeine for use at any level in alcoholic beverages; therefore, these beverages can be lawfully marketed only if their use is subject to a prior sanction or if their use is GRAS.  FDA alerted manufacturers that it is considering whether caffeine can lawfully be added to alcoholic beverages.  In the past year, major brewers Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages (Tilt and Bud Extra, and Sparks) and agreed to not produce any caffeinated alcohol beverages in the future.

Nov 10            FDA Announces Guidance for Industry -  Dosage Delivery Devices for OTC Liquid Drug Products.  This guidance cites examples of dosage cups that may render the product misbranded.  For example, the directions for use specify teaspoon amounts but the cup bears two different graduated scales: teaspoonfuls and tablespoonfuls.  (Editor's note: Apparently, the FDA believes the public can't read.  It this reflective of the current Administration's view of cradle to grave government care?)  You can read the entire document at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM188992.pdf

Nov 9              FDA Approves Drug Treatment for Rare Cancer.   Cutaneous T-cell lymphoma affects about 1,500 Americans annually The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).   More details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189629.htm

Oct 30             Procter & Gamble Unlawfully Marketing Two Vicks Cold and Flu Medicines Containing Vitamin C.   The U.S. Food and Drug Administration today sent a warning letter to Procter & Gamble notifying the company that its Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C are illegally marketed combinations of drug ingredients and a dietary ingredient.

                        Both of the over-the-counter (OTC) medicines, which contain vitamin C in addition to several drug ingredients, are marketed as treatments for cold and flu symptoms. The FDA took the action against the Cincinnati-based company:

                        - To clarify that these single dosage form combinations of drug ingredients and dietary ingredients legally cannot be marketed because they have not been proven safe and effective, and

                        - Because the agency previously determined that there are insufficient data to show that vitamin C is safe and effective in preventing or treating the common cold.

Oct 29             Investigational Drug Regulations Amended. The Food and Drug Administration announced in a Federal Register notice of October 29, 2009, that the agency is amending its investigational new drug application (IND) regulations to add an address for applicants to submit INDs for in vivo bioavailability and bioequivalence studies in humans. INDs for these studies that are intended to support abbreviated new drug applications (ANDAs) should be sent directly to the Office of Generic Drugs. This action is being taken to ensure accuracy and clarity in the agency's regulations.  Details at: http://edocket.access.gpo.gov/2009/pdf/E9-26095.pdf    

Oct 28             SPL Standard for Content of Labeling Technical Qs & As.   The Food and Drug Administration announced in the Federal Register of October 28, 2009, the availability of a draft revised guidance for industry and reviewers entitled ‘‘SPL Standard for Content of Labeling Technical Qs & As.'' This draft guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) inextensible markup language (XML). The draft guidance also provides information to CDER and CBER staff who review and manage that product information using electronic systems. This draft guidance is being revised to reflect technological changes and changes resulting from the requirement in the Food and Drug Administration Amendments Act of 2007 to submit drug establishment registration and drug listing information electronically.  Go to:  http://edocket.access.gpo.gov/2009/pdf/E9-25940.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf

Oct 26             Guidance for Industry:  Investigator Responsibilities. The Food and Drug Administration announced in a Federal Register notice of October 26, 2009, the availability of a guidance for industry entitled ‘‘Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects.'' This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties. http://edocket.access.gpo.gov/2009/pdf/E9-25629.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf

Oct 19             Labeling for Human Prescription Drug and Biological Products. The Food and Drug Administration announced in a Federal Register notice of October 19, 2009, the availability of a guidance for industry and review staff entitled ‘‘Labeling for Human Prescription Drug and Biological Products -Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.'' This guidance is intended to provide applicants and review staff with a definition of established pharmacologic class and to help them identify the most appropriate word (term) or phrase that describes the established pharmacologic class for a drug or biological product for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling. This guidance finalizes the draft guidance published in the Federal Register on May 16, 2007. more at : http://edocket.access.gpo.gov/2009/pdf/E9-24991.pdf  and http://www.fda.gov/downloads/Drugs/

Oct 16             Medical Device User Fee Cover Sheet Notice   The FDA is allowing 60 days for public comment in response to this notice. This notice solicits comments on Form FDA 3601 entitled                                                

``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.  Learn more at: http://edocket.access.gpo.gov/2009/E9-24825.htm

Oct 16             The Commonwealth of Massachusetts Has Issued Emergency Promulgation of Proposed Amendments Authorizing Administration of Vaccines by Designated Health Care Professionals.  This requires the controversial universal, annual vaccination of healthcare workers and health facility employees.  Read more at: http://www.mass.gov/Eeohhs2/docs/dph/regs/reg_vaccine_phc_memo.pdf  

Oct 16             Questions and Answers about Changes to the USP Heparin Monograph.  The U.S. Food and Drug Administration (FDA) has alerted healthcare professionals to changes in the United States Pharmacopeia (USP) monograph for heparin products, effective October 1, 2009. Heparin manufactured after October 1, 2009 will be approximately 10% less potent than heparin manufactured prior to that date.   More at: http://mail.google.com/mail/?shva=1#inbox/1245cdf84938a52c

Oct 16             US Department of Health and Human Services and the Ad Council Launch National Campaign to Help Prevent The Spread of the H1N1 (Swine Flu) Virus.  Health and Human Services Secretary announced today that the Department of Health and Human Services (HHS) is joining with the Ad Council to launch a series of national television public service advertisements (PSAs) designed to encourage Americans to take steps to protect themselves from the 2009 H1N1 flu virus.  To date millions of Americans have gotten the H1N1 flu virus and more than 600 have died since the spring from H1N1 flu-related complications; including children and pregnant women.   Typically 30,000 die each year from complications from the flu.  More information at:  http://www.hhs.gov/news/press/2009pres/10/20091008d.html

Oct 16             FDA Announces Plans for LASIK Quality of Life Project.   The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.  The goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients with significant quality of life problems after LASIK surgery and identify predictors of these problems.   Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.  Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.  Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.  "This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health.  

Oct 16             FDA: Procter & Gamble Warning Posted in Error.  Yesterday, a warning letter to Procter & Gamble regarding Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C products was posted to the FDA Web site in error. The posting occurred due to an internal systems error, and no warning letter has been sent to Procter & Gamble. The agency regrets any confusion caused by the posting.

Oct 16             The NIOSH Science Blog has been updated: "N-95 Respirators and Surgical Masks.  The emergence of H1N1 has created considerable interest about the use of surgical masks and respirators as infection control measures. Given the recent issuance of revised CDC infection control guidance for healthcare personnel includes recommendations for use of N-95 respirators for the protection of healthcare workers from H1N1 instead of surgical masks.  Read more at:  http://mail.google.com/mail/?shva=1#inbox/12458a6657839d9b

Oct 13             Preparation for ICH meetings in St. Louis, Missouri   The Food and Drug Administration (FDA) is announcing a public meeting entitled "Preparation for ICH meetings in St. Louis, Missouri" to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in St. Louis, Missouri, October 24-29, 2009, at which discussion of the topics underway and the future of ICH will continue.   Learn how you , can comment at:  http://www.fda.gov/Drugs/NewsEvents/ucm181849.htm

Oct 13                 FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets   The U.S. Food and Drug Administration today warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain.  These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.  You can learn more about this warning at:   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm186418.htm

Oct 7              HHS Unveils New Features on Flu.gov    Several new resources are now available on the federal government's one-stop resource for flu information -- www.flu.gov . The Web site now features a new H1N1 Self-Evaluation guide for adults 18 and older along with a new Flu Myths and Facts section, which provides the public with the latest and most accurate information about the flu.

Oct 2               Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides the following information on various titles...

Combination Products   The Food and Drug Administration proposed in a Federal Register notice of September 23, 2009, to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for ‘‘single-entity'' and ‘‘co-packaged'' combination products.   More at:  http://edocket.access.gpo.gov/2009/pdf/E9-22850.pdf  

Proprietary Names   The Food and Drug Administration (FDA) announced in a Federal Register notice of October 1, 2009, the opportunity for pharmaceutical firms (applicants) to participate in a voluntary 2-year pilot program for the evaluation of proposed proprietary names to be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). The pilot program will enable participating pharmaceutical firms to evaluate proposed proprietary names and submit the data generated from those evaluations to FDA for review, as outlined in the FDA concept paper entitled ‘‘PDUFA Pilot Project Proprietary Name Review.'' This document describes procedures to register and submit data for applicants who wish to have their proposed proprietary names evaluated under the pilot program.   Details at:  http://edocket.access.gpo.gov/2009/pdf/E9-23620.pdf

                        New MaPP   A MaPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A recent MaPP was issued by the CDER. This MAPP describes procedures to be used in the Center for Drug Evaluation and Research (CDER) by the Office of Surveillance and Epidemiology (OSE), including the Division of Medication Error Prevention and Analysis (DMEPA), the Office of New Drugs (OND), and the Division of Drug Marketing, Advertising, and Communication (DDMAC) in the Office of Medical Policy for handling requests for proprietary name review.   Learn more at: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM182730.pdf

                        Drug Master Files   Another website that is source of useful information:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

                        Women Small Business Owners   The Small Business Administration has introduced its newest online course for women small business owners, Winning Federal Contracts: A Guide for Women Entrepreneurs.  This training module is free, very comprehensive and includes numerous resources, including many targeted for women-owned businesses.   Sign up at:  http://web.sba.gov/sbtn/registration/index.cfm?CourseId=68

                        Small Business Advocate The Small Business Advocate is a publication of the Small Business Administration. The October issue can be read at:  http://www.sba.gov/advo/oct09.pdf

Oct 1               Guidance for Industry:  Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications    This guidance is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

Sept 24           Meetings Announced

                        1)  DIA/FDA Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions, November 3-5, 2009, Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland. Meeting Information and registration can be found at:  http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=20970&eventType=Meeting

2)  DIA/FDA/PhRMA Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, October 28-29, 2009, Marriott Bethesda Pooks Hill, 5151 Pooks Hill Road, Bethesda, Maryland. Meeting Information and registration can be found at: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=20600&eventType=Meeting

Sept 19        Drug Information Update - Public Workshop on Educating the Public About Removal of    Essential Use Designation fo, r Epinephrin, e D.   The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.  The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is holding a public workshop on September 25, 2009 in Rockville, MD to discuss strategies for educating the public about the phase-out of chlorofluorocarbon (CFC)-propelled over-the-counter (OTC) epinephrine inhalers from the US market. The one day workshop will solicit input from key stakeholders in the asthma community, the pharmaceutical industry, experts in health care communication, and the public about how best to alert patients and transition them to therapeutic alternatives.  Read details at:  http://www.fda.gov/Drugs/NewsEvents/ucm180277.htm

Sept 18        Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Inhalation     Solution.   On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.  The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm182867.htm  

Sept 16        CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process.  The Food and Drug Administration (FDA) Center for Drug Evaluation and Research      (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug Process to be held October 15, 2009 at FDA's Center for Food Center for Food Safety and Applied Nutrition (CFSAN) at 5100 Paint Branch Parkway, College Park, MD 20740. Auditorium 1A003.  There is no registration fee.  Space is limited to 225 participants. Registration on the day of the event may be possible on a space availability basis.  More info at:  http://www.fda.gov/Drugs/NewsEvents/ucm182606.htm

 Sept 16       FDA Has Announced the Availability of Draft Guidance for Industry:  Microbiological Data for Systemic Antibacterial Drug Products - Development, Analysis, and Presentation.  A copy is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM182288.pdf     

Sept 15        FDA Clears a Test for Ovarian Cancer That Can Help Identify Potential Malignancies, Guide Surgical Decisions.   The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery.  The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.   OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer.   If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.   OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.   OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer.   The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.  OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass.   It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer.   Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.  More at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182057.htm

Sept 10        FDA Updates "Warning Letters" Web page.  The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:                                                                                                                         1)  Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date posted.                                                                                    2)  Effective Sept. 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.                     3) Additional changes include formatting and improved page navigation to help users understand what searching and browsing options are available.                                              The "Warning Letters" page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the "Warning Letters" webpage in the future.

Sept 10        Unexplained Skin Conditions known as "Morgellons".   CDC continues to receive reports of an unexplained skin condition which some refer to as "Morgellons". Persons who suffer from this condition report a range of cutaneous or skin symptoms including crawling, biting and stinging sensations; granules, threads, fibers, or black speck-like materials on or beneath the skin; and/or skin rashes or sores. In addition to skin symptoms, some sufferers also report fatigue, mental confusion, short term memory loss, joint pain, and changes in vision.               At this time, scientists and doctors do not know what causes this condition. They do not know if people who report the condition have common risk factors or if there is a common cause for the symptoms. To assist in learning more about this condition, CDC is conducting an epidemiologic investigation. To learn more about the investigation, please refer to the following link: www.cdc.gov/unexplaineddermopathy/investigation.html  

Sept  9         CDC Awards $22 Million for Colorectal Cancer Screening Program.  CDC has launched the Colorectal Cancer Control Program (CRCCP) by providing funding to 26 states and tribes across the United States. The program supports population-based screening efforts and provides colorectal cancer screening services to low-income men and women aged 50-64 years who are underinsured or uninsured for screening, when no other insurance is available. 

The funding will support screening and diagnostic follow-up care, patient navigation, data collection and tracking, public education and outreach, provider education, and an evaluation to measure the clinical outcomes, costs, and effectiveness of the program. The local programs are expected to begin screening patients for colorectal cancer within six months.

The Colorectal Cancer Control Program can be accessed through CDC's Division of Cancer Prevention and Control Web site: http://www.cdc.gov/cancer/crccp/.

Read the press release announcing the program: http://www.cdc.gov/media/pressrel/2009/r090908.htm .

Sept  9         Controlling Salt in Your Diet.  The FDA has published information to help people control the amount of salt in their diets.  To read, go to:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm181577.htm

Sept  8         Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products.  The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.  "The FDA is concerned about Care-Tech's products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured," said Deborah Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research. "Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech's customers seek alternative products."   More at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm181654.htm  

Sept 3      &nb, sp;   HHS Awards $70.9 Million to States to Expand Health Insurance Coverage.  HHS Secretary Kathleen Sebelius has announced $70.9 million in grants to 13 states to support the expansion of health care coverage for their uninsured populations. The grants are funded under the new State Health Access Program (SHAP), an outgrowth of the agency's State Planning Grant program that operated from 2000-2007.  This program enabled many states to develop innovative plans that increased health insurance coverage for their uninsured residents.   More can be found at:  http://www.hhs.gov/news/press/2009pres/09/20090903c.html

Sept  1         The September 2009 MedSun (Medical Product Safety Network) Newsletter is now available...  It can be found at:  http://mail.google.com/mail/?shva=1#inbox/123774b72eae8c06

Aug  31        A Parents Guide to Kid's Vaccines is now available at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048750.htm

Aug 27         IMPORTANT NOTICE REGARDING REGISTRATION OF IRBs REVIEWING FDA-REGULATED RESEARCH.  If your IRB reviews FDA-regulated research and you have not submitted an initial registration or provided the FDA-specific information required by FDA's new IRB Registration Rule in the modified OHRP database since July 14, 2009, you are not registered with FDA.   If you have not previously registered your IRB in the OHRP database, you may do so using the new IRB registration submission page at http://ohrp.cit.nih.gov/efile/IrbStart.aspx.  If you are updating your information to provide the FDA-specific information, use the electronic submission system page for updating registrations at http://ohrp.cit.nih.gov/efile/IrbRnwStart.aspx.   For further information on FDA's IRB registration requirements contact Jean Toth-Allen, Ph.D., Office of Good Clinical Practice, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, HF-34, Room 16-85, Rockville, MD 20857, telephone (301) 827-1585, e-mail jean.toth-allen@fda.hhs.gov.

Aug  26        Information from CDER's Small Business Assistance-Electronic Drug Establishment Registration and Drug Listing.    The FDA Amendments Act placed into law the requirement for electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. A series of Structured Product Labeling (SPL) Release training sessions are being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA. information on these training sessions is provided at this website: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm  

In addition to the web conference and face-to-face SPL R4 training sessions, a weekly SPL R4 Q&A/Training session to respond to technical questions related to SPL is being offered to individuals responsible for the preparation and submission of drug establishment registration and drug listing information to the FDA. http://spl-work-group.wikispaces.com/                        For Additional information contact: spl@fda.hhs.gov. 

Aug 25            FDA Authorizes Emergency Use of H1N1 Test for U.S. Troops Serving Overseas.      The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) that allows a 2009 H1N1 influenza virus test to be used to detect the virus in troops serving overseas.  The EUA allows the U.S. Department of Defense to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results.  A EUA authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency.  "The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops. The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  The U.S. Centers for Disease Control and Prevention (CDC) developed the test, which is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR.  More details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm180153.htm

Aug 25         Strategies to Prevent Obesity in the United States.  Learn more about CDC's first comprehensive set of recommended strategies and measures to help communities tackle the problem of obesity through environmental change and policies that promote healthy eating and physical activity at:  http://www.cdc.gov/obesity/data/index.html   In 2008, only one state (Colorado) had a prevalence of obesity less than 20%. Thirty-two states had a prevalence equal to or greater than 25%; six of these states (Alabama, Mississippi, Oklahoma, South Carolina, Tennessee, and West Virginia ) had a prevalence of obesity equal to or greater than 30%.   Blacks had 51 percent higher prevalence of obesity, and Hispanics had 21 percent higher obesity prevalence compared with whites.

Aug 17         Small Business Assistance (SBA) in the Center for Drug Evaluation and Research (CDER) provides assistance to businesses with less than 500 employees in the development of new pharmaceutical products. Through an extensive outreach program SBA provides guidance and information to small pharmaceutical businesses through its ListServ, Q&A's, workshops, and website. The ListServ provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical businesses which includes Federal Register notices, guidance, workshop announcements, etc. The following information is being sent to you via the ListServ

1. Authorized Generic Drugs. The Food and Drug Administration announced in a Federal Register notice of July 28, 2009, the agency is amending its regulations to require that the holder of a new drug application (NDA) submit certain information regarding authorized generic drugs in an annual report. The agency is taking this action as part of its implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA requires that FDA publish a list of all authorized generic drugs included in an annual report since 1999, and that the agency update the list quarterly.  Refer to: http://edocket.access.gpo.gov/2009/pdf/E9-17963.pdf  

2. New Guidance. The Food and Drug Administration announced in a Federal Register notice of July 30, 2009, the availability of a guidance for industry entitled ‘‘Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.   Go to:  http://edocket.access.gpo.gov/2009/pdf/E9-18135.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf   

3. Rates for Prescription Drug User Fees for Fiscal Year (FY) 2010. The Food and Drug Administration announced in a Federal Register notice of August 3, 2009, the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on October 1, 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule. http://edocket.access.gpo.gov/2009/pdf/E9-18457.pdf

4. New Guidance. The Food and Drug Administration announced in a Federal Register notice of August 7, 2009, the availability of a guidance for industry entitled ‘‘Pharmaceutical Components at Risk for Melamine Contamination.'' This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding to better control their use of at-risk components that might be contaminated with melamine. The guidance explains that the agency is recommending that at-risk components be properly tested for melamine contamination before they are used in the manufacture or preparation of drugs or drug products. http://edocket.access.gpo.gov/2009/pdf/E9-18952.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf

5. Warning Letters. The Food and Drug Administration announced in a Federal Register of August 11, 2009, a program to support public health protection by facilitating the timely issuance of warning letters. The program establishes a timeframe for the submission and agency review of post inspection responses to inspectional observations that are communicated to a firm through issuance of a form FDA 483, list of inspectional observations. The program will begin on September 15, 2009. http://edocket.access.gpo.gov/2009/pdf/E9-19107.pdf

6. Charging Patients for Investigational Drugs. The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. This final rule revises the charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use and to clarify what costs can be recovered for an investigational drug. This final rule will permit charging for a broader range of uses than was explicitly permitted. This rule is effective October 13, 2009.  Read more at: http://edocket.access.gpo.gov/2009/pdf/E9-19004.pdf  

7. Expanded Access for Treatment Use.  The Food and Drug Administration announced in a Federal Register notice of August 13, 2009, that the agency is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. This rule is effective October 13, 2009.            ,   Learn more at:  http://edocket.access.gpo.gov/2009/pdf/E9-19005.pdf

8. FDA's Transparency Task Force.  The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency is reopening until November 6, 2009, the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of June 3, 2009 (74 FR 26712). In the notice of public meeting and request for comments, FDA's Transparency Task Force requested comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. The agency is taking this action because the agency is planning a second public meeting this fall and is reopening the comment period to allow interested persons additional time to submit comments.  http://edocket.access.gpo.gov/2009/pdf/E9-19778.pdf  

9. Reorganization of the Office of the Commissioner. The Food and Drug Administration announced in a Federal Register notice of August 18, 2009, that the agency has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the realignment of four Deputy-level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).   http://edocket.access.gpo.gov/2009/pdf/E9-19680.pdf  

10. MaPPs. A MaPP (Manual of Policies and Procedures) is a written statement issued by CDER management to prescribe policies, responsibilities or procedures to be applied within CDER in the conduct of its work or daily operations. A recent MaPP was issued by the CDER. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/UCM174552.pdf

11. The Small Business Advocate. The Small Business Advocate is a publication of the Small Business Administration.  Read at:  http://www.sba.gov/advo/research/sbqei0902.pdf

Aug 17         Keys to Healthy Aging.   What is longevity without health? Adults today are looking not only to extend their lives, but to enjoy their extra years. By 2030, the proportion of the U.S. population aged 65 and older will double to about 71 million older adults, or one in every five Americans. The far-reaching implications of the increasing number of older Americans and their growing diversity will include unprecedented demands on public health, aging services, and the nation's health care system. The Centers for Disease Control and Prevention (CDC) works hard to protect health and promote quality of life through the prevention and control of disease, injury, and disability. CDC has developed some keys to preventing some of the most common health issues facing older adults.  Go To:  http://www.cdc.gov/media/subtopic/matte/pdf/CDCHealthy-Aging.pdf

Jul 16   FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan.  The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain - severe flares of pain that break through regular pain medication.

               Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth's mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use.

               Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, r on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Jul 17     What You Should Know About Novel Influenza A H1N1 (Swine Flu).   Novel influenza A H1N1 (swine flu) is a new flu virus of swine origin that was first detected in April, 2009. On June 11, 2009, the World Health Organization (WHO) raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the novel influenza A (H1N1) virus. A Phase 6 designation indicates that a global pandemic is underway.  You can learn more at:  http://www.cdc.gov/media/subtopic/matte/pdf/CDCNovelH1N1Matte.pdf

Jul 17     Omalizumab (marketed as Xolair): Early Communication about an Ongoing Safety Review.  FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) titled Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) that suggests a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug.  Xolair is approved for use by adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled corticosteroids.  Read the MedWatch safety summary, including a link to the Early Communication about an Ongoing Safety Review, at:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172406.htm

Jul 17     Youth Violence National and State Statistics ~ Monitoring trends in youth violence helps states develop prevention programs and policies that address risk and protective factors.

               To look at youth violence in your state: http://www.cdc.gov/ViolencePrevention/youthviolence/stats_at-a_glance/state_statistics.html  

Jul 17     The following guidances pertaining to Good Clinical Practice are now available:                          1)  Guidance for Industry; Guideline for the Monitoring of Clinical Investigators is at:     http://www.fda.gov/RegulatoryInformation/Guidances/ucm126400.htm.

               2)  The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled `"Development and Use of Risk Minimization Action Plans''. The guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance addresses the development, implementation, and evaluation of risk minimization action plans for drug products.  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126830.pdf

            3) Guidance  ICH Q9: Quality Risk Management    The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073511.pdf   

Jul 15     The following guidances pertaining to Abbreviated New Drug Applications are now available: ANDAs: Impurities in Drug Substances   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172002.pdf         

Jul 15     Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements.   Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs.

Jul 15    Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

   Nexium (esomeprazole magnesium) for Delayed Release Oral Suspension:  There was no statistically significant difference between Nexium and placebo in the rate of discontinuation in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of patients ages 1 to 11 months, inclusive. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD.

Jul 15     FDA MedWatch - Concentrated Acetaminophen Drops: recall of all lots of 16 oz bulk containers by Brookstone Pharmaceuticals, a cautionary measure to minimize potential risk to patients from dosing errors.   Brookstone Pharmaceuticals and FDA notified healthcare professionals and consumers of a nationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. The recalled drops were manufactured by Pharmaceutical Associates, Inc. This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blood disorders. The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

Jul 15     Drug Shortages: Methotrexate Injection.   Bedford Laboratories-The following Bedford products are  on backorder with an estimated release date of September 2009.

25mg/ml (2ml) NDC#55390-031-10                                                                                                      25mg/ml (4ml) NDC#55390-032-10
25mg/ml (10ml) NDC#55390-034-10
25mg/ml (8ml) NDC#55390-033-10

Jul 13     FDA announces the availability of the following guidance:

1)   Guidance for Industry:  Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171672.pdf

2)   Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM171575.pdf

Jul 10     FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers.   The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies. The government's complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.  FDA investigators discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

Jul 10     Inspections, Compliance, Enforcement, and Criminal Investigations - Warning Letters Recently Posted.   Warning letters can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm  

Jul 10     FDA Approves Effient Tablets to Reduce Risk of Heart Attack in Angioplasty Patients.  The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.  The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 percent in patients who received Effient. While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm171497.htm

Jul 8       The American Recovery and Reinvestment Act. The American Recovery and Reinvestment Act contains a package of loan fee reductions, higher guarantees, new Small Business Administration (SBA) programs, secondary market incentives, and enhancements to current SBA programs that will help unlock credit markets and begin economic recovery for the nation's small business sector. The bill provides $730 million to SBA and makes changes to the agency's lending and investment programs so that they can reach more small businesses that need help.  More information at: http://www.sba.gov/recovery/index.html

Jul 8       Registration and Listing. This guidance document intends to assist persons making regulatory submissions to FDA in electronic format. This guidance is designed to assist manufacturers with electronic submissions of drug establishment registration and drug listing information.  You can read the guidance at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072339.pd

Jul 8       Correction of an OTC Document. The Food and Drug Administration in a Federal Register notice of June 30, announced the agency is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs). The document was published with an incorrect Analysis of Impacts section and omitted a reference from the reference section of the final rule. The document was also published with an error in the codified text regarding the introductory sentence to the stomach bleeding warning for NSAIDs. This document replaces the incorrect Analysis of Impacts section with the correct Analysis of Impacts section, adds a reference to the reference section of the final rule, and corrects the codified text.  Learn more at: http://edocket.access.gpo.gov/2009/pdf/E9-15403.pdf

Jul 8       Enforcement Report for July 8, 2009.   The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.  http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm170893.htm 

Jul 8      Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs   As part of the cGMP initiative announced in August of 2002, and to help FDA be more transparent with cGMP policy, the FDA has developed this question and answer resource on Current Good Manufacturing Practices. They intend to use this format to provide timely answers to questions about the meaning and application of cGMPs for human, animal, and biological drugs, and to share these widely. These questions and answers generally clarify statements of existing requirements or policy, and as such, are considered Level 2 guidance. This resource is being co-sponsored by CDER, CVM, CBER, and ORA.  Guidance documents represent the Agency's current thinking on a particular subject 21CFR 10.115).   Questions and answers at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm

Jul 8       Facts About Current Good Manufacturing Practices (cGMPs)  Current Good Manufacturing Practices (cGMPs) for human pharmaceuticals affect every American.  Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.  Most people, however, are not aware of cGMPs, or how FDA assures that drug manufacturing processes meet these basic objectives.  You can read these facts at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm

Jul 8       Recently Posted FDA Warning Letters   These may be searched and viewed at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Jul 7       FDA Takes Action on Darvon and Other Pain Medications  The Food and Drug Administration (FDA) announced actions it was taking to reduce the risk of overdose in people who use pain medications, such as Darvon and Darvocet. These medications contain the drug propoxyphene, which is linked to death from overdoses.  FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. But because of the drug's potential risks, the agency is requiring manufacturers to provide more information to help physicians and patients decide whether propoxyphene is the appropriate pain treatment.  The FDA's actions include:

FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label's boxed warning to emphasize the risk for overdose when using these products.

FDA is requiring manufacturers to provide a medication guide (FDA-approved information that must be given to patients with each prescription or refill) to stress the importance of using the pain drugs only as directed.

FDA is requiring a new safety study to find out more about the effects of propoxyphene on the heart at higher than recommended doses.

FDA is planning to work with other federal agencies, such as the Centers for Medicare and Medicaid Services and the Department of Veterans Affairs, to conduct additional studies on the safety of products that contain propoxyphene as compared to other commonly used pain medications.

FDA has denied a citizen petition from the public interest group Public Citizen requesting a phased withdrawal of propoxyphene.

FDA will further evaluate the safety of propoxyphene and take additional regulatory action, if necessary.

 More information is available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171714.htm

Jul 7       The Division of Drug Information (DDI) is now on Twitter. The DDI is CDER's focal point for public inquiries. It serves the public by providing information on human drug products and drug product regulation by FDA. DDI has recently joined Twitter. For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter:  http://twitter.com/fda_drug_info.

Jul 7       FDA Warns Not to Consume Two Liquid "Energy" Products.  The Food and Drug Administration (FDA) has warned consumers not to buy or use two liquid products that have been recalled due to suspected product tampering.

The products are

•·                     New Whey liquid products

•·                     Hardcore Energize Bullet liquid products

The products are sold in vials that look similar to test tubes. 

The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink and another blade in one vial of New Whey liquid products. No one is known to have been hurt.   Details can be found at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170631.htm

Jul 6       Pediatric Exclusivity Granted.   A list to which FDA has granted pediatric exclusivity for pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act can be found at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm

Jul 1      Are Green Jobs Good for Workers?  Green jobs-good for the environment, good for the economy. But are green jobs good for workers? The National Institute for Occupational Safety and Health (NIOSH) and its partners recently launched the "Going Green: Safe and Healthy Jobs Initiative" to make sure that green jobs are good for workers by integrating worker safety and health into "green jobs" and environmental sustainability.  More at: http://www.cdc.gov/niosh/blog/

Jun 30    FDA Seeks Public Input on Tobacco Regulation  The U.S. Food and Drug Administration announced today that it is seeking public input on the implementation of its historic new authority overseeing tobacco products in the United States. In a Federal Register notice, the agency invites the public to provide information and share views on a wide range of topics, from product content to advertising and marketing. All public comments will be posted online.  The Federal Register notice can be viewed at: http://edocket.access.gpo.gov/2009/pdf/E9-15549.pdf.

Jun 27   Quinine Sulfate (Marketed as Qualaquin): Off-Label Use.  Quinine sulfate is approved by the FDA for treatment of uncomplicated Plasmodium falciparum malaria, a rare disease in the United States. Drug use data indicate that many prescriptions for quinine sulfate are written in this country, most likely for off-label uses (e.g., the treatment of nocturnal leg cramps). Despite taking several regulatory actions to ensure the safe use of quinine, FDA continues to receive reports of serious adverse events associated with this drug. From April 2005 through October 1, 2008, 38 domestic cases with serious outcomes were reported to FDA's Adverse Event Reporting System (AERS). Most reports were of hematologic events, including cases of thrombocytopenia, and resulted in the hospitalization of the patient. Practitioners should be aware that there are no data indicating that quinine is effective for the treatment of nocturnal leg cramps or other musculoskeletal disorders, and given the potential for life-threatening adverse events, should use extreme caution in off-label prescribing.  To learn more go to:
http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm167883.htm#QuinineSulfateMarketedasQualaquin:Off-LabelNotApprovedbyFDAUseofQuinine 

Jul 6       FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer.  The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.  Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient fo, r cell replication.  To learn more, visit:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170515.htm

Jul 2       Chantix and Zyban, Smoking Cessation Drugs, to Get Boxed Warning on Serious Mental Health Events.   On July 1, 2009, the U.S. Food and Drug Administration (FDA) announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.  Health care professionals who prescribe Chantix and Zyban should monitor patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm170356.htm 

Jun 24    FDA Approves Generic Prescription-Only Version of Plan B Emergency Contraceptive for Women Ages 17 and Under.   The U.S. Food and Drug Administration today approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. The generic product will be available by prescription only for women ages 17 and under.  

Plan B was first approved in 1999 for prescription use only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescription-only product for women ages 17 and under. Today's approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif. 

Details at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm

Jun 17    MedWatch - Cefepime: FDA determined that data review do not indicate a higher rate of death in cefepime-treated patients.  FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications. FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime.  More info at: http://mail.google.com/mail/?shva=1#inbox/121eef6c924ca122  

Jun 16    Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products.   On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient - benzamidenafil - a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED).   More can be read at: http://www.fda.gov/Safety/Recalls/ucm167139.htm

Jun 16    Process Begins to Define "Meaningful Use" of Electronic Health Records.  The Recovery Act provides Medicare and Medicaid incentive payments to eligible providers, such as physicians and hospitals, in order to increase the adoption of electronic health records (EHRs). To receive the incentive payments, providers must demonstrate "meaningful use" of a certified EHR. Building upon the work done by the HIT Policy Committee, the Centers for Medicare & Medicaid Services (CMS), along with the Office of the National Coordinator for Health Information Technology (ONC), will be developing a proposed rule that provides greater detail on the incentive program and proposes a definition of meaningful use. CMS expects to issue the proposed rule in late 2009, which will be followed by a comment period.  More information is available at: http://www.hhs.gov/news/press/2009pres/06/20090616a.html

Jun 16    FDA Advises Consumers Not To Use Certain Zicam Cold Remedies.  The U.S. Food and Drug Administration today advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

The products are:                                                                                                                                 Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) (a discontinued product)                        More detail at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

Jun 15     MedWatch - Stimulant Medication in Children with AD/HD - FDA perspective on study data published about potential risks of AD/HD Simulant Medications. Products involved include: Focalin, Focalin XR (dexmethylphenidate HCl ); Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostat (dextroamphetamine sulfate); Vyvanse (lisdexamfetamine dimesylate); Desoxyn (methamphetamine); Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate); Adderall, Adderall XR (mixed salts amphetamine); Cylert (pemoline) and generics.  This study, funded by the FDA and the National Institute of Mental Health (NIMH), compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children. Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child's stimulant medication.  Read the complete MedWatch 2009 Safety Summary, including a link to the Communication and the FDA News Release, at:                                                                        http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm

Jun 13    FDA Issues Public Health Advisory Regarding Levemir Insulin.  The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166358.htm

Jun 11    FDA Approves Injectable Form of Ibuprofen.   The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever.

"Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options," said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA's Center for Drug Evaluation and Research. "But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products."

               Caldolor will be available for hospital use only.

               More info at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165971.htm                 

Jun 10   New and Improved FDA Website.    Recently FDA has launched their new and improved website with an updated look and better searchability.  All offices within the FDA have had their websites incorporated under the main FDA webpage.   The FDA studio now has two websites - one for internal programming to FDA employees and one for external programming for both FDA employees and any outside organizations and industry to watch.  Please note that the internal site is only accessible to FDA.  External site:  http://www.fda.gov/AboutFDA/CentersOffices/CDRH/DivisionofCommunicationMediaFDATVStudio/default.htm 

  Jun 10  Recalls  More information can be found at:  http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=87#1

               Raptiva Withdrawn from the Market    Prescribers should work with patients to transition to alternative psoriasis therapies.  Genentech is conducting a phased market withdrawal of the psoriasis drug Raptiva (efalizumab). The company is doing this because taking the drug carries the risk of developing progressive multifocal leukoencephalopathy (PML). PML, which is caused by the JC virus, is a rapidly progressive and irreversible infection of the central nervous system that leads to death or severe disability. Although the overall risk of PML for patients on Raptiva is low, it appears to be increased in long-term users of the drug and in those with compromised immune systems.

               Recalls of Digoxin and Propafenone Tablets   Cardiac drugs recalled because of a possible variation in tablet size.  FDA has posted information about two cardiac drugs that were recently recalled because of variability in the size of the tablets:

Caraco Pharmaceutical Laboratories, a manufacturer of generic pharmaceuticals, recalled some of their digoxin tablets. Included in the recall are 0.125 and 0.25 mg tablets that were distributed prior to March 31, 2009 and which show an expiration date of September, 2011.

Because of the variation in tablet size, these products could contain either more or less than the labeled amount of digoxin. Digoxin has a narrow therapeutic index, which means that small variations in tablet potency could have serious effects. Too much of the drug can cause digoxin toxicity, which can include hypotension and cardiac instability and may lead to death. Too little can lessen the drug's effectiveness, which can also lead to cardiac instability.

Watson Pharmaceuticals recalled one lot of 225 mg propafenone HCL tablets, packaged in bottles of 100, because they may contain slightly more than the labeled amount of the drug. The recalled tablets show an expiration date of July 31, 2010. Like digoxin, propafenone has a narrow therapeutic index, and too much of the drug can cause hypotension and arrhythmias.

Patients and providers should report problems they encounter with any of these recalled products to FDA's MedWatch program.

               Recall of Zencore Plus   Consumers taking organic nitrates who also took Zencore Plus may experience a sudden and profound drop in blood pressure.  Bodee LLC is recalling its supplement product called Zencore Plus after FDA laboratory analysis showed that the product contains benzamidenafil. This is a newly discovered PDE5 inhibitor that is likely to have the same pharmacologic properties as sildenafil, tadalafil, and vardenafil, which have been approved by FDA for the treatment of erectile dysfunction.

A person taking organic nitrates who also took Zencore Plus could experience a sudden and profound drop in blood pressure, which would pose a significant health risk.

Zencore Plus capsules, which were supplied by Hi-Tech Pharmaceuticals, have been sold in health food stores, by mail order and on the internet. People who have this product should stop using it immediately.

Jun 10   Warning Letters.  Recent Warning Letters may be found at  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Jun 9     HHS Secretary Sebelius Releases New Report on Health Disparities - Minorities, Low Income      Americans More Likely to Be Sick, Less Likely to Get Care  U.S. Health and Human Services (HHS) Secretary Kathleen Sebelius today released a new report on health disparities in America and participated in a White House Health Care Stakeholder Discussion on the importance of reform that reduces disparities that exist in our current health care system. The new report Health Disparities: A Case for Closing the Gap is available at http://www.healthreform.gov/ .                          

               Under the status quo:

•·               Forty-eight percent of all African Americans adults suffer from a chronic disease compared to         39 percent of the general population.

•·               Eight percent of white Americans develop diabetes while 15 percent of African Americans, 14 percent of Hispanics, and 18 percent of American Indians develop diabetes.

•·               Hispanics were one-third less likely to be counseled on obesity than were whites -- only 44 percent of Hispanics received counseling.

•·               African Americans are 15 percent more likely to be obese than whites.

Jun 9    Skin Products Made by Clarcon being recalled  FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse. Read the complete MedWatch 2009 Safety summary, including a link to the FDA News Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165028.htm

Jun 8     California Man Sentenced for Prescription Drug Diversion  CONCORD, NEW HAMPSHIRE: Thomas Lavery, of Irvine, CA, was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork. Judge McAuliffe also entered an order of forfeiture against Lavery for the sum of $1,009,460.

Jun  8     FDA Reposts Its Requirement For Boxed Warning for All Botulinum Toxin Products.  Prompted by reports of serious adverse events, the U.S. Food and Drug Administration on April 30  announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.                                  The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.                                                                       These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.                                                      The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.  The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.         You can learn more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149574.htm

Jun 8      Final Product-Specific Bioequivalence (BE) Recommendations. The Food and Drug Administration announced in a Federal Register notice of June 8, 2009, the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide products specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. http://edocket.access.gpo.gov/2009/pdf/E9-13261.pdf

Jun 5     Flu Weekly Report and Flu Weekly Map for Centers for Disease Control and Prevention (CDC). This information is updated frequently and is now available at http://www.cdc.gov/flu/weekly/  and  http://www.cdc.gov/flu/weekly/usmap.htm

Jun 4     The FDA Data Standards Council's SPL web page was updated Thursday, June 4, 2009, to provide the following updates:

Session 14 - June 19, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing Bulk Ingredient/Bulk Product Electronic Drug Listing Submissions

Session 15 - June 26, 2009, Web Conference 9:00 - 10:30 a.m. - SPL R4 Training - Preparing OTC Drug Product Electronic Drug Listing Submissions

See this web page for more details:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm

Jun 3      FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug  The U.S. Food and Drug Administration today warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease.  "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA's Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."   Propylthiouracil was approved for marketing in 1947.  More information at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm164207.htm

Jun  3  The Food and Drug Administration announced in a Federal Register notice of June 3, 2009, the availability of a draft guidance for industry and researchers entitled ‘‘The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application.''   This draft guidance provides information to those using radioactive drugs for certain research purposes to help determine whether research studies may be conducted under an FDA-approved radioactive drug research committee, or whether research studies must be conducted under an investigational new drug application(IND). It also offers answers to frequently asked questions on conducting research with radioactive drugs, and provides information on the membership, functions, and reporting requirements of a radioactive drug research committee approved by FDA. http://edocket.access.gpo.gov/2009/pdf/E9-12832.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM163892.pdf   

Jun 2     FDA is announcing the formation of a Transparency Task Force to recommend ways to  improve the openness and transparency of the agency's information. This will help make useful and understandable information about FDA activities and decision making more readily available.   Carrying out the task force's recommendations should make agency actions, decisions, and underlying processes more transparent to the public, while still meeting the agency's goal of appropriately protecting confidential information. Further, carrying out the recommendations should also reduce the need for requests by the public for agency information under the Freedom of Information Act (FOIA).   More information is at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm163900.htm 

Jun 2      Guidance Documents   Guidance documents represent FDA's current thinking on a topic.  They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you believe an FDA employee is not following FDA's Good Guidance Practice regulations (21 CFR 10.115) or the Office of Management and Budget's Bulletin No. 07-02(M-07-07) Final Bulletin for Agency Good Guidance Practices (January 18, 2007),  you should contact the employee's supervisor in the issuing office or Center.  If the issue is not resolved, contact the next highest supervisor or the Center's Ombudsman.  If the issue is still not resolved, contact the FDA's Office of the Ombudsman at:                                                          FDA Office of the Ombudsman
5600 Fishers Lane, Rm. 13B-07  
Rockville, MD 20857
Phone:                 301-827-3390        
Fax:  301-480-8039
Email:  Ombuds@oc.fda.gov

Jun 1     The Food and Drug Administration announced in a Federal Register notice of June 1, 2009, the availability of a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.'' This guidance document is designed to assist industry (e.g.,manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing information. Specifically, the document provides guidance to industry on the types of information to include for purposes of drug establishment registration and drug listing and on how to prepare and submit the information in an electronic format that FDA can process, review, and archive. http://edocket.access.gpo.gov/2009/pdf/E9-12743.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072339.pdf     

May 27  The Food and Drug Administration announced in a Federal Register notice of May 27, 2008, the availability of a draft guidance for industry entitled ``Presenting Risk Information in Prescription Drug and Medical Device Promotion.'' This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and device promotional pieces to determine whether they adequately present risk information. The guidance describes and discusses the factors FDA considers when evaluating prescription drug advertisements (ads), restricted device ads, and prescription drug and device promotional labeling for their compliance with the Federal Food, Drug, and Cosmetic Act (the act) and relevant regulations. The guidance gives examples to illustrate FDA's thinking on these factors and is intended to help regulated industry gain a better understanding of what they should consider as they develop the content and format of their promotional communications. http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-12255.pdf  and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM155480.pdf

May 27  FDA Announces Minor Use/Minor Species (MUMS) Grant Program  The Food and Drug Administration today announced the initiation of a grant program to support the development of new animal drugs intended for minor species or minor uses in major species. (Major species are horses, dogs, cats, cattle, pigs, turkeys and chickens.)

The implementing regulations for Designation were finalized in July 2007, and Congress appropriated money to support the program in March of this year.                                                 FDA now has $750,000 to offer in MUMS grants for the fiscal year ending September 30, 2009.  You can read more at:  http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm161627.htm

May 19   Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants is available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf

May 19   Final Rule to Require Organ Specific Warnings. The Food and Drug Administration announced in a Federal Register notice of April 29, 2009, a final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA). http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9684.pdf

May 19   Deaths - Final Data for 2006  The age-adjusted death rate in 2006 was a record low. The death rates for males declined between 2005 and 2006 for age groups 1-4 years, 5-14 years, 35-44 years, 45-54 years, 55-64 years, 65-74 years, 75-84 years, and 85 years and over. The largest statistically significant decrease for males occurred among those aged 1-4 years (8.7 percent). The only statistically significant increase (2.4 percent) in the age-specific death rate among males occurred for those aged 25-34 years.   http://www.cdc.gov/nchs/data/nvsr/nvsr57/nvsr57_14.pdf

May 19   Current Drug Shortages: Morphine Sulfate Oral Solution, Roxane- has product available. See information in Related Information section, Mallinckrodt- Increased demand due to another manufacturer leaving the market, Lannett-Increased demand due to another manufacturer leaving the market, and Glenmark- Increased demand due to another manufacturer leaving the market. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

May 18   MedWatch April 2009 Safety Labeling Changes - 65 drugs with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions      The April 2009 posting includes 65 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.                                                                            The following 45 drugs had modifications to the BOXED WARNING, CONTRA, INDICATIONS, and WARNINGS sections:   Extraneal, Remicade, Orap, Prevpac, Soma Compund, Aleve, Aleve Liquid Gels, Aleve-D Sinus & Cold, Axert, Carbatrol, Celontin, Depakene, Depakote, Depakote ER, Depakote Sprinkle, Depo-Medrol, Dilantin, Doribax, Enlon Plus, Equetro, Exjade, Felbatol, Gabitril, Heparin Solium injection, Ibuprofen, Kaletra, Keppra/Keppra XR, Klonipin, Lamictal, Lyrica, Midol, Motrin, Children's Motrin Cold, Mysoline, Neurontin, Peganone, Sarafem, Stavzor, Tarceva, Tegretol, Topamax, Tranxene, Treanda, Tridione, Trileptal, Zarontin, Zonegran                                        The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/medwatch/safety/2009/apr09_quickview.htm                                                     The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections: http://www.fda.gov/medwatch/safety/2009/apr09.htm

May 15   CDC Travel Health Warning for Novel H1N1 Flu in Mexico Removed  CDC's Travel Health Warning recommending against non-essential travel to Mexico, in effect since April 27, 2009, has now been downgraded to a Travel Health Precaution for Mexico.  http://wwwn.cdc.gov/travel/content/travel-health-precaution/novel-h1n1-flu-mexico.aspx

May 15   New Labeling Required for OTC Pain and Fever Medicines  On April 28, 2009, FDA issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling.   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149573.htm

May 15   Resolved Drug Shortages - Fentanyl Transdermal Patch http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm

May 14   Drug Shortages - Oxycodone Immediate Release Tablets (5mg, 15mg and 30mg)     http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050793.htm

May 11   AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability  A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin.   http://www.fda.gov/Safety/Recalls/default.htm

May 11   FDA Alerts Consumers to Recall of Water-Based Face Paints  Fun Express, Inc. recalls children's face paint associated with adverse events.   The Food and Drug Administration is advising consumers to stop using certain cosmetic "Face Paint" items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.   The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory.   The following Face Paints manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China, are being voluntarily recalled by Fun Express Inc., a wholly-owned subsidiary of Oriental Trading Co.  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152301.htm

May 11   Dietary Supplements Worth $1.3 Million Condemned and Forfeited to the United States Under Consent Decree At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed on the Internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL.   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152358.htm

May 8     FDA Approves Drug for Treatment of Aggressive Brain Cancer.  The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm152295.htm

May 7     Safety Concerns for Testosterone Gel   Side effects in children prompt additional warnings on testosterone gel products for adults.  The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).  In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child.  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149580.htm

May 1     The FDA is warning consumers to immediately stop using Hydroxycut products.  These products are manufactured by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.  Hydroxycut products are dietary supplements that are marketed for weight loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.   http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm152152.htm

specialty pharma newsletter january 2013 prepared feb 11 2013 final.doc

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