New Industry News

Specialty Pharma Newsletter (April - July 2016)

July 16      Voluntary nationwide recall of oral liquid docusate sodium manufactured by PharmaTech and distributed by Rugby Laboratories- Drug Information Update.  U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.  FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.

July 15      Guidance for Industry:  Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product under Section 503A of the Federal Food Drug and Cosmetic Act.  To obtain your copy download at:   Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

July 15     Guidance for Industry: Compounded Drug Products That Are Copies of Approved Drug Products.       To obtain your copy download at:   Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Also the FDA released a this notice announcing the two guidance on Compounding:  FDA issues proposals to implement statutory restrictions on compounding drugs that are essentially copies of commercially available or approved drugs

July 15      FDA Approves an Increase to the Amount of Vitamin D for Milk and Milk Alternatives.  The                       approval, which amends existing food additive regulations, will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.  Manufacturers may begin using the new amounts on July 18, 2016.

July 13      FDA Posts Notice Announcing a Change in its Procedure for Inspections of Certain Human Drug                   Compounders Starting August 1, 2016.  Read at notice 

July 12      Drug Information Update - FDA approves new medication for dry eye disease.  The U.S. Food                     and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of  drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.  The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia).  Safety and efficacy in pediatric patients below the age of 17 years has not been studied.

July 12      Guidance for Industry:  Updating ANDA Labeling After the Marketing Application for the                   Reference Listed Drug Has Been Withdrawn.  Download your copy by Control /Click on this link:                     “Updating ANDA Labeling after the Marketing Application for the Reference Listed Drug (RLD) Has                        Been Withdrawn.”  

July 12      Paragraph IV Patent Certifications.  The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Division of Filing Review at 240-402-8859, before making any decisions based on this information.

                  Go to Paragraph IV Patent Certifications (PPIV) (PDF - 2.3MB) by Control/Click on the colored statement.    

July 11      Public Notifications:  The Following Products Contain Hidden Drug Ingredients.  Dream Body                   Advanced, Acai Weight Loss & Cleanse, Dream Body Extreme Gold, Dream Body Original Formula, Extra Slim Plus Acai Berry Weight Loss Formula, and SBF Bee Pollen.

July 8        FDA Approves First Retinoid Drug for Over-The-Counter (OTC) Use to Treat Acne - Drug                   Information Update.  The U.S. Food and Drug Administration approved Differin Gel 0.1% (adapalene),  a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.  Differin Gel 0.1% should not be used on damaged skin (for example, cuts, abrasions, eczema, or sunburn). People using Differin Gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips and mouth.    

July 1        You  Can Search all FDA Official Guidance Documents and Other Regulatory Guidance by Using this Website:  Control/Click on:     Search all FDA official guidance documents and other regulatory guidance

June 30     Guidance for Industry:  Elemental Impurities in Drug Products Guidance for Industry                (PDF - 100KB)  Control/Click on the colored print above to read.

June 30   FDA requests additional information to address data gaps for consumer hand sanitizers.  The FDA today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC).  The FDA’s request for more data is intended to help the agency ensure that regular use of these products does not present unknown safety and efficacy concerns, and does not mean the FDA believes these products are ineffective or unsafe.  The proposed rule will be available for public comment for 180 days. Concurrently, companies will have one year to submit new data and information, and comments on any new data or information may then be submitted to the docket for an additional 60 days. 

June 28     FDA approves Epclusa for treatment of chronic Hepatitis C virus infection.  The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug, and is the first to treat all six major forms of HCV.  Epclusa was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

June 24     Quality Metrics Technical Conformance Guide: Technical Specifications Document (PDF - 114KB)  To review your copy, Control/Click on the above colored title.

June 24     The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.  A new CDER Conversation has posted. The topic is the generic drug approval process, featuring Ted Sherwood, Director, Office of Regulatory Operations, Office of Generic Drugs, CDER. The U.S. Food and Drug Administration requires a generic drug company produce enough data to demonstrate it can make a drug that can be appropriately substituted for its brand-name counterpart. The challenge for the generic drug maker is to prove to FDA that the generic version is substitutable with a brand-name drug that has been shown to be safe and effective. FDA’s challenge is to carefully review that data to ensure it proves the same thing. This conversation discusses how both do their job. For more information, please visit: The Generic Drug Approval Process by Control/Click on the colored title in this sentence.

June 22     FDA Drug Shortage.  Theophylline Extended Release Tablets and Capsules (Updated - Currently in Shortage)

June 21     Racial disparities in stroke incidence and death.  A stroke occurs when blood vessels that supply the brain become ruptured or blocked. When blood can’t bring nutrients and oxygen to brain cells, the cells stop functioning and die.  Studies have found that black people between the ages of 45 and 54 die of strokes at a rate that’s 3 times greater than their white counterparts. This difference declines with increasing age, so that by the age of 85 it no longer exists.

June 17         Guidance for Industry: Quality Attribute Considerations for Chewable Tablets.  View by Control/Click on this link  Quality Attribute Considerations for Chewable Tablets Guidance for Industry

June 16     FDA seeks input on product-specific recommendations to facilitate generic drug development.  FDA has published 33 product-specific recommendations (18 new and 15 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.  For more information and to view the recommendations, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm 

June 14     Redefining health and well-being in older adults.   Based on the NIH health information topics you requested to receive information about, the FDA thought you'd be interested in this story from NIH Research Matters:  https://www.nih.gov/news-events/nih-research-matters/redefining-health-well-being-older-adults

June 13     New update to the Drug Safety Communication on Zecuity (sumatriptan)- Drug Information Update.  Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine.

June 10     OTC Monograph User Fees Public Meeting Was Held on June 10th.   FDA held a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs. A user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph.

June 9       Pharmacy Compounding.  FDA issues final guidances on interim policy for certain bulk drug substances used in compounding.  See at:  http://www.fda.gov/Drugs/DrugSafety/ucm502075.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery  (paste in browser)

June 9       FDA Guidance on Pharmacy Compounding.  Read by Control/Click on  Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance

June 9       FDA finalizes interim policy on compounding using bulk drug substances   Today the FDA issued                   two final guidances on compounding using bulk substances:

·               Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the                   Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 127KB)

·               Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the                   Federal Food, Drug, and Cosmetic Act (PDF - 106KB)                                                        The agency also posted a statement and a webpage related to these two guidances: 

·               FDA issues final guidances on interim policy for certain bulk drug substances used in compounding

·               Safety Risks Associated with Certain Bulk Drug Substances Nominated for Use in Compounding; Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. For more information on pharmacy compounding, go to FDA’s Information on Compounding

 June 9      Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Guidance for Industry.  The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND.   Federal Register Notice      Guidance Document

June 9       FDA Drug Safety Podcast: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch.   On June 2, 2016, FDA announced it is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.  Patients should not bathe, shower, or swim while wearing the patch. Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the patch immediately. Consider a different formulation of sumatriptan or switch patients to an alternative medicine. Evaluate patients and application site as needed.The Zecuity patch is designed to deliver a dose of medicine by way of a single-use, battery-powered patch wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.  Since marketing began in September 2015, a large number of patients have reported experiencing burns or scars on the skin where the patch was worn. Reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. We are investigating to determine whether future regulatory action is needed.

June 9       FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX-Drug Information Update.  The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. This effort was part of Operation Pangea IX, the Ninth Annual International Internet Week of Action (IIWA), a global cooperative effort, led by INTERPOL, to combat the unlawful sale and distribution of illegal and potentially counterfeit medical products on the internet.  

June 9      FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin. 

                  On June 6, 2016, FDA warned consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.   OTC aspirin-antacid products are sold under various trade names, including Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever. They are also available as generics.  Taking more of these medicines than the amount recommended or for a longer period than recommended will increase the risk of serious bleeding.      

June 8       Nature Made® Recalls Various Products Because of Possible Health Risk.  Pharmavite LLC is recalling specific lots of Nature Made® products detailed  below due to possible Salmonella or Staphylococcus aureus contamination.                                                          Nature Made® Adult Gummies Multi          

                        Nature Made® Adult Gummies Multi + Omega-3                                                                                                    Nature Made® Adult Gummies Multi for Her plus Omega-3s

                        Nature Made® Super B Complex w/C & Folic Acid Tablet

June 8       New Drug Safety Communication on Imodium (loperamide) and loperamide products – Drug Information Update.  The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide.

June 7       Can You Lengthen Your Life?  Researchers Explore How To Stay Healthy Longer.  “If I had to rank behaviors in terms of priority, I’d say that exercise is the most important thing associated with living longer and healthier,” says Dr. Luigi Ferrucci, an NIH geriatrician who oversees research on aging and health. “Exercise is especially important for lengthening active life expectancy, which is life without disease and without physical and mental/thinking disability.”

June 6       FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death.  Control/Click to read

June 1       FDA approves Zinbryta to treat multiple sclerosis.  The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.  “Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.  Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. 

June 1       FDA approves Ocaliva for rare, chronic liver disease.  On Friday, May 27, the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.  PBC is a chronic, or long lasting, disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed.  “Patients left untreated, or who have not responded to UDCA, are at risk for liver failure and death,”

May 31     FDA approves new diagnostic imaging agent to detect recurrent prostate cancer.  The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.  “Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Axumin is shown to provide another accurate imaging approach for these patients.”

May 26     FDA approves new implant for the treatment of opioid dependence.  The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.  Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. Probuphine consists of four, one-inch-long rods that are implanted under the skin on the inside of the upper arm and provide treatment for six months. Administering Probuphine requires specific training because it must be surgically inserted and removed.

May 26     The FDA has finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA).   It will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply.   Under the new rule, both domestic and foreign food facilities, for the first time, are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.

May 23     Prescription Drug User Fee Act (PDUFA).  The President signed into law the Food and Drug Administration Safety and Innovation Act1 (FDASIA), which includes the reauthorization of PDUFA through September 2017. PDUFA V will provide for the continued timely review of new drug and biologic license applications.

                  The FY 2016 user fee rates have been published (posted 8/3/2015):

                  Application with Clinical                                               $ 2,374,200

                  Application without Clinical                                             1,187,100

                  Supplement with Clinical                                                  1,187,100

                  Product                                                                                114,450

                  Establishment                                                                       585,200

May 19     CDER SBIA Chronicles: FDA Embraces Emerging Technology for Bioequivalence of Locally Acting Nasal Sprays.  Download the FDA/CDER Chronicles at: https://mail.google.com/mail/u/0/?ui=2&ik=c74809db4c&view=pt&search=inbox&msg=154c9d6c4ba9a433&siml=154c9d6c4ba9a433

May 19     Well Care Compounding Pharmacy, Las Vegas, Nevada is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to the Food and Drug Administration’s (FDA) concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016.

May 18     Drug Information Update- New Drug Safety Communication on Canagliflozin.  The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). We have not determined whether canagliflozin increases the risk of leg and foot amputations. We are currently investigating this new safety issue and will update the public when we have more information.

May 13      SOS Telecom, Inc. Recalls New Unapproved   Drugs Marked as Dietary Supplements.  SOS Telecom, Inc. of Bayside, NY is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil. Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making this tainted dietary supplement and unapproved drug.  Products affected:  Tiger-X, Ninja-X, Genseng Power-X, Super Samurai-X.  These products were marketed as dietary supplements for male sexual enhancement. 

May 13     FDA advises health care professionals that counterfeit BiCNU has been discovered in some foreign countries.  The FDA is informing health care professionals that a counterfeit version of the FDA approved cancer drug, BiCNU (carmustine for injection) 100 mg, has been detected in some foreign countries. There is no indication at this time that counterfeit BiCNU has entered the legitimate U.S. drug supply chain and no indication that any U.S. patients have received counterfeit BiCNU.  The authentic product is approved to treat different types of brain cancer, multiple myeloma, and lymphoma (Hodgkin’s and non-Hodgkin’s). BiCNU is manufactured by Emcure Pharmaceuticals Ltd. and distributed in the United States by Heritage Pharmaceuticals Inc.

May 12     FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together.  The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.  An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.

May 12     FDA Issues Final Guidance on Frequently Asked Questions About Medical Foods. m The U.S. Food and Drug Administration has published a resource to give industry more information about the definition and labeling of medical foods.  The final guidance for industry “Frequently Asked Questions About Medical Foods: Second Edition,” represents FDA’s current thinking on medical foods. This second edition, which finalizes the August 2013 draft guidance, provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance.  Medical foods are specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are not those foods simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.  Control/Click on: Final Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition

May 10     Statement on FDA’s Actions on Labeling of KIND Products.  In March 2015, the FDA issued a warning letter to KIND LLC, because the labels and labeling of KIND’s products bore a variety of nutrient content claims but the products did not meet the requirements to make such claims.  Following receipt of the closeout letter, KIND requested confirmation that it could use the phrase “healthy and tasty” only in text clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information. In our discussions with KIND, we understood the company’s position as wanting to use “healthy and tasty” as part of its corporate philosophy, as opposed to using “healthy” in the context of a nutrient content claim,  Consumers want to make informed food choices and it is the FDA’s responsibility to help them by ensuring labels provide accurate and reliable nutrition information. In light of evolving nutrition research, forthcoming Nutrition Facts Labeling final rules, and a citizen petition, we believe now is an opportune time to reevaluate regulations concerning nutrient content claims, generally, including the term “healthy.”

May 6       The Generic Drug User Fee Amendments of 2012 (GDUFA) Fiscal year 2017 self-identification reporting period is open from May 1st to June 1^st, 2016. Self-Identification is an annual requirement, whether or not company information has changed.  GDUFA requires that human generic drug facilities and certain sites and organizations identified in a generic drug submission provide identification information annually to FDA.  We also offer the following web-based learning courses to help you understand GDUFA:                                                                                                                                              1.  Overview of the Generic Drug User Fee Amendments of 2012                                                                             

2.  Generic Drug User Fee Amendments Self-Identification Structured Product Labeling (SPL) Submission Part 1 and Part 2   (Use Control/Click on blue/violet statements to view)

May 5      FDA reminds health care professionals not to use drug products intended to be sterile from Medaus.  The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile.  Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.  The majority of these drugs are hormone replacement products, such as injectables and implantable pellets, and injectable nutritional products, such as vitamins, minerals and amino acids.  Medaus’ drug products intended to be sterile were distributed nationwide and were also exported internationally. 

May 4       FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S.  The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other.

May 3       New Drug Safety Communication on aripiprazole.  The U.S. Food and Drug Administration (FDA) is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced.   As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

May 3       New Drug Safety Communication on Brintellix (vortioxetine).  The U.S. Food and Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016.

May 3       FDA Approves First Drug to Treat Hallucinations and Delusions Associated with Parkinson’s Disease.  The U.S. Food and Drug Administration approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.  Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.  

Apr 30      , Federal judge enters order of permanent injunction against Paul W. Franck.  The U.S. Food and Drug Administration announced that U.S. District Judge Carlos E. Mendoza entered an order of permanent injunction against Paul W. Franck of Ocala, Florida. According to the complaint filed with the consent decree, Franck manufactured and distributed drug products that were adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The U.S. Department of Justice brought the action on behalf of the FDA.  The order prohibits Franck from manufacturing, holding and distributing sterile drug products until he complies with the FD&C Act and its regulations, in addition to other requirements.  

Apr 29      Guidance - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.   Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496288.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                  or control/click on:  Facility Definition Under Section 503B of the Federal Food, Drug, a, , nd Cosmetic Act

Apr 29      FDA approves first generic Crestor.  The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets.   Generic drugs approved by the FDA have the same quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.  Watson Pharmaceuticals Inc. of Parsippany, New Jersey has received approval to market generic rosuvastatin calcium in multiple strengths.  (Editor's note:  As of June 2016 the price of the generic was about the same as the brand [Crestor].  Typically it takes 6 to 9 months for the generic price to fall to competitive generic levels)

Apr 29      FDA Regulation of Marijuana.    Download slides by control/click on:                                                            FDA Regulation of Marijuana: Past Actions, Future Plans

Apr 28      Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples.

Apr 18      Three New Draft Guidance Related to Compounding of Human Drugs.  These apply to both outsourcing facilities and compounders seeking to operate under section 503A.

                Guidance :  Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 82KB)   Control/Click to view guidance.

                Guidance :  Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 296KB)   Control/Click to view guidance.

                     Draft Guidance: Hospital and Health System Compounding Under the Federal Food, Drug, and       Cosmetic Act    Control/Click to view guidance.

Apr 11      Guidance for Industry:   Contents of a Complete Submission for the Evaluation of Proprietary Names      Control/Click to view guidance.

Apr 8        New Drug Safety Communication on metformin.  The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function.  We have concluded from the review of studies published in the medical literature that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. We are requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.

Mar 25      Draft Guidance:  General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral       Opioid Drug Products.  Control/Click on: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry    

Mar 24      FDA Warns Consumers Not to Use “Best Bentonite Clay”.  “Best Bentonite Clay,” is a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk.  Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.

Mar 23      New Drug Safety Communication: FDA warns about several safety issues with opioid pain medicines and requires label changes.   The U.S. Food and Drug Administration (FDA) is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels.   Opioids are a class of powerful narcotic pain medicines that are used to treat moderate to severe pain that may not respond well to other pain medicines (see List of Opioids). They can help manage pain when other treatments and medicines are not able to provide enough pain relief, but they also have serious risks including misuse and abuse, addiction, overdose, and death.

                  List of Opioids  alfentanil - Alfenta;   buprenorphine - Belbuca, Bunavail, Buprenex, Butrans, Suboxone, Zubsolv;    butorphanol - No brand name currently marketed;    codeine - Fioricet w/ codeine, Fiorinal w/ codeine, Tylenol w/ codeine;     dihydrocodeine - Synalgos-DC;     fentanyl - Abstral, Actiq, Duragesic, Fentora, Ionsys, Lazanda, Sublimaze, Subsys;    hydrocodone - Anexsia, Hysingla ER, Lortab, Norco, Reprexain, Vicodin, Vicoprofen, Zohydro ER;    hydromorphone - Dilaudid, Dilaudid-HP, Exalgo;    meperidine - Demerol;    methadone - Dolophine, Methadose;    morphine - Astramorph PF, Duramorph PF, Embeda, Infumorph, Kadian, Morphabond, MS Contin;    oxycodone - Oxaydo, Oxycet, Oxycontin, Percocet, Percodan, Roxicet, Roxicodone, Xartemis XR;   oxymorphone - Opana, Opana ER;    pentazocine- Talwin;    remifentanil - Ultiva;    sufentanil - Sufenta;    tapentadol - Nucynta, Nucynta ER;    and    tramadol - Conzip, Ultracet, Ultram, Ultram ER          

Mar 16      FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals.  The U.S. Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used.  The plastic safety seal or tamper-evident ring, also known as a collar, or band, should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. A loose safety seal or ring presents a safety risk as it may cause eye injuries.  Consumers and health care providers who have these products should not attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper.

Specialty Pharma Newsletter (January - March 10, 2016)

Mar 10      Nestlé USA Announces Voluntary Recall of a Limited Number of DiGiorno® Pizzas, Lean Cuisine® and Stouffer’s® Products Due to the Potential Presence of Foreign Material (Glass Pieces).  Consumers who may have purchased the products listed above should not consume them but should instead contact Nestlé Consumer Services at 1-800-681-1676.  A list of products with UPC and Best Before Dates is available at:   http://www.fda.gov/Safety/Recalls/ucm490200.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 10     Drug Information Update:  FDA alerts health care professionals and patients not to use human and animal sterile drug products produced and distributed by I.V. Specialty, Ltd. Austin, TX due to lack of sterility assurance.   During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.  On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. 

Mar 10     FDA Issues Final Guidance for Industry on How to Reduce Acrylamide in Certain Foods,  The U.S. Food and Drug Administration (FDA) has issued final guidance to the food industry to help growers, manufacturers and food service operators take steps to reduce levels of acrylamide in certain foods.   Acrylamide is a chemical that may form in certain foods during high-temperature cooking, such as frying, roasting and baking. The National Toxicology Program (an interagency program that evaluates possible health risks associated with exposure to certain chemicals) characterizes the substance as “reasonably anticipated to be a human carcinogen.” The focus of this non-binding guidance is on raw materials, processing practices, and ingredients pertaining to potato-based foods (such as french fries and potato chips), cereal-based foods (such as cookies, crackers, breakfast cereals and toasted bread), and coffee, all sources of acrylamide exposure. Additional advice to consumers pertaining to acrylamide, including recommended food storage and preparation methods, is available on FDA.gov.

Mar 9        Today, the U.S. Food and Drug Administration approved the first generic version of Viagra (sildenafil citrate), for the treatment of erectile dysfunction.  Teva Pharmaceutical Industries received approval to market generic sildenafil citrate tablets in 25 mg, 50 mg, and 100 mg strengths and has 180-day exclusivity.  For information about the availability of these products, contact the manufacturer.

Mar 9        FDA statement on Menu Labeling Enforcement  As a result of language in the omnibus appropriations bill enacted December 18, 2015 (Public Law 114-113 Consolidated Appropriations Act, 2016), FDA is delaying enforcement from December 1, 2016, to the date that is one year after it issues final, Level 1 guidance on menu labeling. The draft Level 1 guidance was issued on Sept. 11, 2015, and FDA is considering all comments received and will issue the final guidance as soon as possible.

Mar 9        CDER Small Business and Industry Assistance (SBIA) announces the Regulatory Education for Industry (REdI) conference "Generic Drugs Forum 2016" at the Doubletree Hotel in Silver Spring, MD. April 13-14, 2016.  This event is free.  For info and registration paste this link into your browser:  http://sbiaevents.com/?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Mar 9        Warning Letters                                                                                                                                        Raphah, Inc., P.O. Box 7166, North Brunswick, New Jersey 08902                                                     Recent FDA inspection of Raphah's dietary supplement manufacturing facility in New Brunswick, New Jersey revealed a number of significant violations of 21CFR Part 111 cGMP regulations for dietary supplements.  Among the violations: failure to establish specifications for components, for in-process manufacturing steps, for labeling and packaging, and for finished "Bioenergy" products and their labeling.  Failure to follow a written manufacturing record (MMR) for each unique formulation.  Failure to conduct identity testing, and failure to conduct tests and examinations and conducting a material review.                                                                                                                            .

                  Herbal Energetics/In Joy Organics, 32 Bay Hill Road, Northfield, New Hampshire 03276

                  Recent FDA inspection of your facility revealed that your products  “X Out-Rays,” “Stop It Cold,” “SOS Flower Essence,” “Decongest,” “Smoke No More,” “Goodbye Pain,” “Cough Release for Babies and Small Children,” “Cough Release,” “Childrens Stop It…Cold Flu,” “Viral Resolve,” and “Flu the Coop.” are intended for use as unapproved new drugs.

                  VitaSea Products Int’l, Inc. dba Wachters Organic Sea Products, 550 Sylvan St., Daly City, CA 94014

                  We (FDA) evaluated your website at Internet address www.wachters.com and determined that claims on your website establish your products as intended for use as unapproved new drugs.

                  Gordondale Farms, Inc., P.O. Box 26, Nelsonville, Wisconsin 54458-0026

                  We (FDA) found that you offered for sale an animal for slaughter as food that was adulterated.  Our investigation also found that you hold animals under conditions that fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply.   Failure to take prompt action to correct this situation may result in regulatory action without further notice such as seizure and/or injunction.

                  HoneyCombs  Industries, LLC., 10671 6075 Road, Montrose, Colorado 81403

                  An inspection of your dietary supplement manufacturing facility located at 10671 6075 Road, Montrose, Colorado revealed that your products Cough Syrup, Formula C&F (Cold & Flu) Liquid Alcohol Free Extract, Month 6 (Parasites & Microbes), and Formula P (Parasites, Children & Elderly) Liquid Alcohol Free Extract are intended for use in the cure, mitigation, treatment, or prevention of disease and are considered to be unapproved new drugs.

                  Chemolee Lab Corporation, 3820 Conflans Road, Irving, Texas 75061

                  During a recent FDA inspection we identified significant violations of current Good Manufacturing Practices (cGMP) for finished pharmaceuticals.  Among violations we found that the following products are unapproved and/or misbranded drugs in violation of the FD&C Act: (b)(4) Restless Legs Cream, (b)(4) Restless Legs Cream, (b)(4) Shingles Anti-Itch Recovery Cream, (b)(4) Shingles Recovery Cream Anti-Itch Formula, (b)(4) Lung Cream Herbal Formula, (b)(4) Anti-Inflammatory & Pain Relief Cream, (b)(4) Diabetic Foot Cream Anti-Itch Formula, and (b)(4).            

                  Sharim Distributing Co., Inc., 1115 W. Hayward Avenue, Independence, Missouri  64052

                  FDA has determined that certain products you distribute, including but not limited to, “(b)(4) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FD&C Act [21 U.S.C. §§ 352 and 331(a)].  FDA confirmed through laboratory analysis that “(b)(4)” contain the following undeclared phosphodiesterase type-5 (PDE-5) inhibitors: sildenafil  and dithiodesmethylcarbodenafil.  These products are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in their labeling.

Mar 8        Guidance for Industry: 

                  Environmental Assessment: Q & A Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity.  The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses.  Environmental Assessments must be submitted as part of certain NDAs, abbreviated new drug applications (ANDAs), biologic license applications (BLAs), supplements to such applications, and investigational new drug applications (INDs).   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444658.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                  Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of TransfusionTransmission of Zika Virus.  We, FDA, are providing you, blood establishments that collect Whole Blood and blood components, with recommendations for donor screening, donor deferral and product management to reduce the risk of transfusion-transmitted Zika virus (ZIKV).  Download at:

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM486360.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 26       FDA Posts Questions and Answers on Spice Safety.   For more information Control/Click on the link:                                                                                                  Questions & Answers on Improving the Safety of Spices

Feb 26       CDERLearn.   CDERLearn, the web page for educational tutorials offered by the Center for Drug Evaluation and Research (CDER). 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.   To learn more paste this address into your browser:  http://www.fda.gov/Training/ForHealthProfessionals/ucm090162.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 23       Senescent cells tied to health and longevity in mice.  Removing senescent cells — those that had stopped dividing — extended the lifespan of mice and had other health benefits without apparent side effects.  The results suggest that therapies aimed at removing senescent cells could help counter some effects of aging.   Taking advantage of the fact that senescent cells express certain unique genes, they designed transgenic mice in which injection of a drug triggers senescent cells' death.   Cellular senescence is a biological mechanism that functions as an ‘emergency brake’ used by damaged cells to stop dividing.   While halting cell division of these cells is important for cancer prevention, it has been theorized that once the ‘emergency brake’ has been pulled, these cells are no longer necessary.

Feb 19       Drug Information Update- FDA approves new drug to treat partial onset seizures.  The U.S. Food and Drug Administration approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.   The most common side effects reported by people taking Briviact in clinical trials included drowsiness, dizziness, fatigue, nausea and vomiting.   As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks. 

Feb 17       Enforcement Report - Class III

                  Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only.    Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540.  Reason:  Failed Impurities/Degradation Specifications; 9 month stability timepoint.

Feb 12       Guidance for Industry

                  (Instructions to download the following three documents: (control + click on the colored link, then right click and "select" the address in the pop up, then press "enter", then click on the download arrow at the right hand corner of your screen to view)

                  Completeness Assessments for Type II API DMFs Under GDUFA .  For a copy, select this link:  Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry

                  Allergic Rhinitis: Developing Drug Products for Treatment.  For a copy, select this link: 

                   Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry 

                  Nonallergic Rhinitis: Developing Drug Products for Treatment.   For a copy, select this link: 

                   Nonallergic Rhinitis: Developing Drug Products for Treatment

Feb 11     Drug Information Update - FDA alerts compounding pharmacies of a nationwide voluntary recall of SyrSpend SF and SyrSpend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast (Candida galli).   If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.

Feb 5         Products that Contain Hidden Ingredients.

                  Genseng Power X, Boss Number Six, Golden Night, Mamba is a Hero, Ninja-X contain hidden ingredients which are sildenafil and sulfoaildenafil; tadalafil; sildenafil, and hydroxythiohomosildenafil; sildenafil, desmethyl carbodenafil, and dapoxetine; sildenafil and thiosildenafil, respectively.

Feb 10       Enforcement Report - Class II

                  Lyrica (pregabalin) capsules, 50 mg & 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017.  Reason:  FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

                  Nystatin, USP Powder for Rx compounding, 150 Million Units and 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427.  Reason:  Labeling: label error on declared strength.

Feb 5         Products that Contain Hidden Ingredients.

                  Genseng Power X, Boss Number Six, Golden Night, Mamba is a Hero, Ninja-X contain hidden ingredients which are sildenafil and sulfoaildenafil; tadalafil; sildenafil, and hydroxythiohomosildenafil; sildenafil, desmethyl carbodenafil, and dapoxetine; sildenafil and thiosildenafil, respectively.     Black Ant, Herb Viagra, Real Skill, Stree Overlord, Weekend Prince, and African Black Ant all contain sildenafil.   Wonder-Erect Male Gum and Wonder Erect Male Pills contain vardenafil (Levitra).

Feb 1         Drug Information Update - FDA is reminding consumers to be wary of so-called “chelation” products that are marketed over-the-counter.  The U.S. Food and Drug Administration (FDA) is reminding consumers to be wary of so-called “chelation” products that are marketed over-the-counter (OTC) to prevent or treat diseases such as lead poisoning. Companies that make unapproved products often highlight that their product contains the same ingredient as an FDA-approved drug, suggesting that it is OK for them to market their drug without FDA approval.  These products are not FDA approved.  Chelation involves the use of certain chemicals to remove heavy metals from the body.  In medicine, chelation has been used for the treatment of metal poisoning, among other conditions.  FDA has never approved any chelation product for OTC use for any health condition.  All FDA-approved chelation products require a prescription because they can only be used safely under the supervision of a health care practitioner.  Illegal OTC chelation products are frequently marketed to deceive consumers into thinking they are taking a product that has been evaluated by FDA. 

Jan 29       The Food and Drug Administration (FDA) is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning.  FDA laboratory analysis identified mercury in the product.  Exposure to mercury can cause serious health problems, such as kidney and nervous system damage.  Mercury can also interfere with brain development in children. Signs and symptoms of mercury poisoning include, irritability, shyness, tremors, changes in vision or hearing, memory problems, depression, and numbness and tingling in hands, feet or around the mouth.  Consumers are encouraged to report unlawful sales of products, including “Crema Piel De Seda,” to FDA through our website at: Reporting Unlawful Sales of Medical Products on the Internet.

Jan 29       Drug Information Update - FDA warns consumers about health risks with Alikay Naturals – Bentonite Me Baby – Bentonite Clay due to potential lead poisoning risk.  “Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.

Jan 28       FDA seeks input on product-specific recommendations to facilitate generic drug development.  FDA has published 47 product-specific recommendations (35 new and 12 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.  FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of BE guidances.  For more information and to view the recommendations, visit http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075207.htm

Jan 28       Drug Information Update - FDA approves first drug to show survival benefit in liposarcoma.  The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.  Soft tissue sarcoma (STS) is a disease in which cancer cells form in the soft tissues of the body, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. Liposarcoma is a specific type of STS that occurs in fat cells. STS can form almost anywhere in the body, but is most common in the head, neck, arms, legs, trunk and abdomen.

Jan 26       Schedule for Guidance that CDER is Planning to Publish During Calendar Year 2016.  You can download your copy at:   Guidance Agenda: Guidances CDER is Planning to Publish During Calendar Year 2016

                  (control + click on the colored link, then right click and "select" the address in the pop up, then press "enter", then click on the download arrow at the right hand corner of your screen to view)

Jan 21       FDA/CDER SBIA Chronicles -  Best Communications Practices with FDA.   Issues of this newsletter are archived at http://www.fda.gov/cdersmallbusinesschronicles

Jan 20       Enforcement Report

                  DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02.  Reason:  Failed Impurities/Degradation Specifications - High out of specification test result for impurities during stability testing.

Jan 19       FDA Warns Consumers Not to Use Licorice Coughing Liquid.  The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine.  The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine,  consumers who are hypersensitive to morphine could suffer severe allergic reactions if they take this product.  This product is manufactured by Ma Ying Long Pharmaceutical Group in China and distributed in the U.S. by Master Herbs USA, Inc. in Pomona, CA. The distributor has agreed to recall the product.

Jan 5         Draft Guidance

                  Unique Device Identification: Convenience Kits.  You can obtain a copy at:

                  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm479242.pdf

                  Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base.   You can obtain a copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm478821.pdf

Dec 31       Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph.

                  FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.  To see the Federal Register Notice on this topic

                  control + click on  Federal Register Notice     or paste this address into your browser:  https://www.federalregister.gov/articles/2015/12/23/2015-32246/fixed-combination-and-co-packaged-drugs-applications-for-approval-and-combinations-of-active?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery

Dec 28       Medication Fraud - More Products with Hidden Drug Ingredients.

                  Rhino Big Horn, Rhino 7 Blue 9000, OrgaZen 3500, OrgaZen 3000, Triple Miracle Zen Plus,

                  Triple Miracle Zen Gold, Triple Miracle Zen Extreme, Eros Power Zone 1900, and Diamond 3500.

                  They contain ingredients like desmethyl carbodenafil, sildenafil, tadalafil, dapoxetine, etc.

Specialty Pharma Newsletter (April –July 2015) 

Jul 24        FDA Proposes Additional Revisions to the Nutrition Facts Label.  The supplemental proposal would, among other things, require declaration of the percent daily value (%DV) for added sugars. The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families.  The FDA is accepting public comments starting July 27, 2015.  For more information go to:  http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

July 24      Life and More issues recall of Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.

July 22      Enforcement Reports                                                                                                                                          Class III:                                                                                                                                   HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL.   Reason for Recall:  Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable.                                                                          Class II:                                                                                                                                       Nitroglycerin Transdermal System 0.2 mg/hr. (10 cm2) and 0.4 mg/hr. (10cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-0 Reason for Recall:  Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.   

July 22      Warning Letters                                                                                                                                                Vista Pharmaceuticals Ltd., Nalgonda District Andhra Pradesh 508254 India   Dr. Dhananjaya Alli  failed to pay the appropriate facility fee as required by the Generic Drug User Fee Amendments of 2012 (GDUFA).   Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded, or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded, or processed at such a facility are misbranded. 

Jul 17        Guidance for Industry.  Testicular Toxicity: Evaluation During Drug Development (Draft).  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455102.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Jul 15        Enforcement Reports                                                                                                                             Class I                                                                                                                                                             Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11.  Reason for Recall:  Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.                  

 Jul 15        Class II                                                                                                                                              Losartan potassium tablets USP, 25 mg, 50 mg, and 100 mg, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9    Reason for Recall:  Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.                                                                                    Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.  Reason for Recall:  CGMP Deviations: Firm did not adequately investigate customer complaints.

Jul 14        CDER SBIA Chronicles:  “Import-Export” May 2014.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM454794.pdf

Jul 13        FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes.  Patients taking NSAIDs should seek medical attention immediately if they experience symptoms such as chest pain, shortness of breath or trouble breathing, weakness in one part or side of their body, or slurred speech.   Examples of NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib 

Jul 13        FDA Drug Shortages:                                                                                                                     Morphine Sulfate (Avinza) Extended Release Capsules have been discontinued.     

Jul 10        FDA Approved Rexulti (brexpiprazole) Tablets to Treat Adults with Schizophrenia and as an Add-on Treatment to an Antidepressant Medication to Treat Adults with Major Depressive Disorder (MDD).   MDD, commonly referred to as depression, is also a severe and disabling brain disorder characterized by mood changes and other symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities.  

Jul 8          FDA approves new drug to treat heart failure.  The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.  Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure generally worsens over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

Jul 6          Guidance For Industry                                                                                                                              The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy.  This guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving product tracing information, prior to or at the time of a transaction or do not capture and maintain the product tracing information, as required by the FD&C Act.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm453225.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                   

    Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.  This guidance discusses FDA recommendations for the size, shape, and other physical attributes of generic tablets and capsules intended to be swallowed intact. FDA is concerned that differences in these physical characteristics between generic drugs and the originator drug could affect patient outcomes.  Get your copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm377938.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

     Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations.  FDA is seeking public comment on whether the uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated products currently designated essential are no longer essential under the Clean Air Act due to the availability of alternatives that do not use CFCs or because the products are no longer being marketed. Essential-use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act.  Read the Federal Register Notice at:  https://www.federalregister.gov/articles/2015/06/29/2015-15902/use-of-ozone-depleting-substances-request-for-comment-concerning-essential-use-designations?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery  

Jun 22       FDA approves new antiplatelet drug used during heart procedure.  The FDA approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.   According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year.

Jun 19       Guidance for Industry:  Naming of Drug Products Containing Salt Drug Substances.  Read this guidance at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm379753.pdf

Jun 15       FDA alerts health care providers, researchers and patients not to use certain products from ScienceLab.com   FDA investigators inspected the headquarters of ScienceLab.com in Houston, Texas and observed conditions that could result in a lack of sterility of purportedly sterile drug products, which puts patients at risk.  FDA asks health care providers to report to FDA if they have sterile product from ScienceLab.com in inventory by sending an email to: 

Jun 11       Guidance for Industry                                                                                                                   Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Product – Content and Format.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450636.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 June 10     Enforcement Reports    Class II                                                                                                                                       Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.   Reason for  Recall:  Failed Dissolution Specifications: Low out of specification dissolution results.

                  Zebeta® (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01  Reason for Recall:  Failed Dissolution Specifications: OOS result during stability testing 

                  SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433   Reason for Recall:   Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Hon,, ey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

                  Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02.  Reason for Recall:   cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

                  Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02.  Reason for Recall:   cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure. 

Jun 10       FDA Issues Draft Guidance on Developing Drugs for Duchenne Muscular Distrophy.  Read at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM450229.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jun 8         Medication Disposal: Questions and Answers.   Website address: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 29   Guidance for Industry:                                                                                                                                  1.   ANDA Submissions – Refuse-to-Receive Standards.  Download your copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm370352.pdf                                                                                                    2.   Established Conditions – Reportable CMC Changes for Approved Drug and Biologic Products (DRAFT).   Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM448638.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 May 28     FDA Drug Shortages:                                                                                                                                    1.   Methylphenidate hydrochloride ER Capsules/Tablets                                                                       2.   Gemifloxacin Meslate (Factive) Tablets                     

May 28     FDA Approves Rapamune to treat lymphangioleiomyoatosis (LAM), a very rare lung disease that attacks women of childbearing age.  LAM is characterized by an abnormal growth of smooth muscle cells that invade lung tissues, including the airways, and blood/lymph vessels that cause destruction of the lung, resulting in airflow obstruction, and limiting the delivery of oxygen to the body. LAM is a very rare disease. According to the U.S. National Library of Medicine, only between two and five women per million women worldwide are known to have the disease.

May 28     FDA approves two therapies to treat IBS-D.  The U.S. Food and Drug Administration approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.  According to the National Institutes of Health, patients with irritable bowel syndrome (IBS) experience a number of signs and symptoms, including pain or discomfort in the abdomen and changes in bowel movement patterns. Studies estimate that IBS affects 10 to 15 percent of adults in the United States. IBS-D is a subtype characterized mainly by loose or watery stools at least 25 percent of the time.

May 22   Guidance for Industry:                                                                                                                                  1. Compounding Animal Drugs from Bulk Drug Substances.  Read at: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-av-gen/documents/document/ucm446862.pdf 

May 22     FDA Warns That SGLT2 Inhibitors for Diabetes May Result in a Serious Condition of Too Much Acid in the Blood.  Type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors.  SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes.  SGLT2 inhibitors are not FDA approved for patients with type 1 diabetes, as safety and efficacy have not been established.

May 21     FDA Cautions About Dose Confusion and Medication Errors for Antibacterial Drug Zerbaxa.  FDA is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.  To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Thus, one vial of Zerbaxa will now list the strength as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram. 

May 20     CDER SBIA Chronicles:  “Patents and Exclusivity” May 2014.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM447307.pdf

 May 18     Orange Book (updated)                                                                                                                                     1.  April 2015 Additions and Deletions to the Drug Product List.  Read at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM447006.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                                    2.  Cumulative Supplement 6 June 2015.   Read at:  http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 18     FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Rx Drugs.   For information on safe purchasing practices, see FDA’s Know Your Source Campaign:  http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm389121.htm

May 15     Guidance for Industry:                                                                                                                                 1.   Investigational New Drug Applications Prepared and Submitted By Sponsor-Investigators.   Download at:   http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm446695.pdf                                                                                           2.   Biosimilars:  Additional Questions and Answers Regarding Implementation of Biologics Price Competition and Innovation Act of 2009.  Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm273001.pdf

May 15     Inactive Ingredients Database Download.   Go to:  http://www.fda.gov/Drugs/InformationOnDrugs/ucm113978.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                                                           Inactive Ingredient Search for Approved Drug Products.  Go to:  http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm?source=govdelivery&utm_medium=email&utm_source=govdelivery

May 15     FDA Drug Shortages:                                                                                                                                   1.  Chloroquine Phosphate Tablets        

May 14     Guidance for Industry                                                                                                                                    1.  Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.  Get your copy at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm333969.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                  2.  Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (DRAFT).  This document is available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070246.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery      

 May 13     Enforcement Reports  Class I                                                                                                                                 ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068. Reason for Recall:  Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein 

                  0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.  Reason for Recall:   Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.

May 13     Enforcement Reports  Class II                                                                                                                   C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414  Reason for Recall:  Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL   

May 12     The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection.     Plague is extremely rare in most parts of the world, including the United States, with 1,000 to 2,000 cases worldwide each year. The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague and septicemic plague.  Plague can be spread to humans through bites from infected fleas, contact with infected animals or humans, or laboratory exposure. The bacteria that causes plague, Yersinia pestis, is considered a biological threat agent that could potentially be used as a bioterrorism agent.

May 8       Guidance for Industry:                                                                                                                                 1.  Changes to Approved NADAs – New NADAs vs. Category II Supplemental NADAs.   Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-av-gen/documents/document/ucm052460.pdf                                                                                    2.  Waver of In Vivo BA and BE Studies for Immediate Release Solid Dosage Forms Based on a Biopharmaceutics Classification System (DRAFT).  Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070246.pdf                                                                                            3.   Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.  Download at:   http://www.fda.gov/ucm/groups/fdagov-public/documents/document/ucm291128.pdf

May 5       Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil® (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL) Due to Particulate Matter.

                  Mylan Initiates Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter:  Gemcitabine, Methotrexate, Carboplatin, and Cytarabine

 Apr 30       Public Notification - The following products contain hidden drug ingredients:                              1. Slim Forte Slimming Capsule                                                                                                                        2. Li Da Dai Dai Hua Slimming Capsule                                                                                                3. King of Romance                                                                                                                                4. Viagra 007                                                                                                                                                 5. Black Panther                                                                                                                                               6. Extreme Diamond 3000                                                                                                                        7. Akttive Capsules                                                                                                                                8. Zero Xtreme Capsules                                                                                                                                9. Pyrola Advanced Joint Formula                                                                                                         10. SmartLipo

Apr 30      FDA approves treatment for fat below the chin  The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat.   Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.

Apr 28      Drug Information Update - FDA approves first generic Abilify to treat mental illnesses.  Generic Abilify (aripiprazole). is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Apr 27       FDA Issues a Letter for Manufacturers with Recommendations on Fluoride Added to Bottled Water.  he U.S. Food and Drug Administration (FDA) has issued a letter to industry recommending that bottled water manufacturers, distributors and importers limit the amount of fluoride they add to bottled water so that it contains no more than 0.7 milligrams per liter (mg/L).  The PHS recommendation replaces a previous recommendation for fluoride concentrations that ranged from 0.7-1.2 mg/L, and is designed to achieve an optimal fluoride level that provides the best balance of protection from dental caries while limiting the risk of dental fluorosis

Apr 22       Guidance For Industry:                                                                                                                               1.  Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs (DRAFT).  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 17       Enforcement Report – Class I                                                                                                               0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.   Reason for Recall:  Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.      

Apr 15       The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.  Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.

Apr 7         CDER SBIA Pre-R, ecorded Webinar:  Risk Evaluation and Mitigation Strategies: Modifications and Revisions - Guidance for Industry                                                                                                         View Webinar Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions           -Listen to Webinar (Audio Only) Here: Risk Evaluation and Mitigation Strategies: Modifications and Revisions (MP3 - 44.2MB)                                                                                                                -Download Presentation Slides: Risk Evaluation and Mitigation Strategies: Modifications and Revisions (PDF - 2.22MB)                                                                                                    Download the Guidance:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM441226.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery           

Apr 2         The U.S. Food and Drug Administration has issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.  Opioid drugs provide significant benefit for patients when used properly; however opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.  Download the guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 2         CDER Key Official List.   Download at:   http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/UCM070722.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 2        Draft Guidance for Industry; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products.  This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (“products”). This draft guidance revises the guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants” published May 19, 2009.   Read Federal Register Notice at:   https://www.federalregister.gov/articles/2015/03/11/2015-05523/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-applicants-of-prescription?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery

Specialty Pharma Newsletter (January – March 2015)

Mar 31      Draft Guidance – Development and Submission of Near Infrared Analytical Procedures.  You can download this document at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM440247.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 30      The U.S. Food and Drug Administration (FDA) is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). We have changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a newContraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous (IV) iron replacement product. Patients should immediately alert their health care professional or seek emergency care if they develop breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration. 

Mar 25     Recalls – Class II                                                                                                                                                 Comfort Gel Maximum Strength Antacid & Anti-Gas (Aluminum hydroxide 400 mg, Magnesium hydroxide 400 mg, Simethicone 40 mg in each 5 mL, 1 teaspoon) liquid, 12 FL OZ (355 mL) bottle. Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, Recalled by Tarmac Products, Inc., Reason:  Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.                                                                                                                                                                           

Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle. Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015.  Recalled by Tarmac Products, Inc.  Reason:  Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

Mar 25     The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept)    injection to treat diabetic retinopathy in patients with diabetic macular edema.  Diabetic retinopathy (DR) is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years.

Mar 25     Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century.   The Food and Drug Administration (FDA) is announcing a public hearing to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic.  Date:  April 20-21, 2015, Time: 9:00 am to 4:00 pm.  Location: FDA White Oak Campus, 10903 New Hampshire Avenue Bldg. 31, Room 1503A (Great Room) Silver Spring, Maryland 20993.  Contact Information: 

Mar 23     NIH Research Matters: Physical Activity May Reduce Age-Related Movement Problems.  Age-related brain lesions known as white matter hyperintensities have been linked to movement problems and disabilities later in life. These lesions, which appear as bright spots on MRI images, can be used as a proxy measure of brain white matter disease. They are thought to reflect small blood vessel disease, and have also have been associated with dementia and other health issues in older people.  Read more at:  http://www.nih.gov/researchmatters/march2015/03232015movement.htm

Mar 23  New Guidance Document Search Feature.  A new feature on the FDA.gov website allows you to search for guidance documents for all topics across the site from one convenient location:   http://www.fda.gov/RegulatoryInformation/Guidances/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 23      Guidance for Industry: Electronic Submission of Lot Distribution Reports (LDRs)  Under 21 CFR 600.81 applicants must submit to CBER or CDER, as appropriate, LDRs containing certain specified information every 6 months about the quantity of product distributed under their approved biologic license application (BLA) [including to distributors].  Download at:  http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM412006.pdf 

Mar 20      FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic.  OTC asthma products labeled as homeopathic are widely distributed through retail stores and via the internet. Many of these products are promoted as “natural,” “safe and effective,” and include indications that range from treatment for acute asthma symptoms, to temporary relief of minor asthma symptoms. In general, consumers can identify such products by looking for the word “HOMEOPATHIC” or “HOMŒOPATHIC” on a product’s label and looking for whether the product’s active ingredient(s) are listed in terms of dilution (e.g., “LM1” "6X" or "30C"). Read more at:  http://www.fda.gov/Drugs/DrugSafety/ucm438976.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Mar 19     CDER Small Business Chronicles:  Drug Master Files 101.  The topic of this month’s issue of the FDA/CDER Small Business Chronicles is titled “DMF 101” and serves as an introduction to the Drug Master File (DMF). It is possible for a firm submitting an application to FDA to incorporate confidential information submitted by another firm.  This is done via a DMF. The DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs are generally created to allow a party other than the DMF holder to reference material without disclosing to that party the contents of the file.  Get your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM438678.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 18     Public Notification: Ultimate Boost, Xcel and Xcel Advanced contain hidden drug ingredients.   Ultimate Boost and Xcel Advanced contain phenolphthalein. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  Xcel contains fluoxetine. Fluoxetine is an FDA- approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD).  Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.  In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.                                     This notification is to inform the public of a growing trend of 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 that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.  

Mar 18      The U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease, steatorrhea (presence of fat in the stool) and complications from decreased fat-soluble vitamin absorption.  Individuals with these rare disorders lack the enzymes needed to synthesize cholic acid, a primary bile acid normally produced in the liver from cholesterol. The absence of cholic acid in these patients leads to reduced bile flow, accumulation of potentially toxic bile acid intermediates in the liver (cholestasis), and malabsorption of fats and fat-soluble vitamins in the diet. If untreated, patients fail to grow and can develop life-threatening liver injury. 

Mar 10     Ultra ZX LABS, L.L.C. Issues Voluntary Nationwide Recall of Ultra ZX Since It Contains Undeclared Sibutramine and Phenolphthalein.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.   Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States.

Mar 10      Guidance for Industry – Formal Meetings between the FDA and Sponsors or Applicants of PDUFA (Prescription Drug User Fee Act) Products.  Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM437431.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 10     The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.   Neuroblastoma is a rare cancer that forms from immature nerve cells. Unituxin is an antibody that binds to the surface of neuroblastoma cells. Unituxin is being approved for use as part of a multimodality regimen, including surgery, chemotherapy and radiation therapy for patients who achieved at least a partial response to prior first-line multiagent, multimodality therapy.

Mar  9      The U.S. Food and Drug Administration (FDA) is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. In addition, rare accounts of seizures in patients treated with Chantix have been reported. We have approved changes to the Chantix label to warn about these risks. Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately. 

Mar  9       FDA approves first biosimilar product Zarxio.  FDA approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.  Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.   Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen.

Mar  9       Draft Guidance for Industry: Clinical Trial Imaging Endpoint Process Standards.  This guidance assists sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that FDA regards as important when imaging is used to assess a trial's primary endpoint or a component of that endpoint. This draft guidance revises the draft guidance entitled “Standards for Clinical Trial Imaging Endpoints” issued on August 19, 2011.  Get your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM268555.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar  9       Draft Guidance for Industry:  Clinical Investigators, and Institutional Review Boards: Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers.  This guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.  Download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar  6       The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.  Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis is caused by the Mucorales fungi. These infections occur most often in people with weakened immune systems.  Cresemba belongs to a class of drugs called azole antifungal agents, which target the cell wall of a fungus. Cresemba is available in oral and intravenous formulations.

Mar  6         Public Notification:  Bigger Longer More Time More Sperms (sic), Black Ant King, African Superman, Black Mamba Premium, Black Mamba Hyperrush and L-Carnitine Sob Strengthening Version Slimming Miracle Capsule all contain hidden drug ingredients.  Bigger Longer More Time More Sperms (sic), Black Ant King, African Superman and Happy Passengers  contain Viagra (sildenafil).                              Black Mamba Hyperrush, and L-Carnitine Sob Strengthening Version Slimming Miracle Capsule contain sibutramine. 

Mar  4      The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.  Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.

Mar 4        Drug Information Update - FDA launches drug shortages mobile app.  Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.  The app identifies current drug shortages, resolved shortages and discontinuations of drug products.  The app is available for free download via iTunes (for Apple devices) and Google Play store (for Android devices) by searching “FDA Drug Shortages.”

Mar 4        FDA is hosting the Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2016 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2016 Regulatory Science Plan.  The meeting will be held at FDA’s main campus in Silver Spring, MD, on June 5, 2015, from 9:00am-5:00pmand will be webcast for those who cannot attend in person.

Mar 4        Public Notification: The following products contain the undeclared ingredient sildenafil:   Sex Men, Super Hard, Santi Scalper, Plant Vigra, MME Maxman, and Eliminating Weight & Toxin Keeping Beauty, Night Man, Tibet Babao, 72HP, Vigra, Vigour 300, Hard Wang, FX 3000, Germany Niubian, and Black King Kong

Mar 4        Public Notification: Seven Slim and Nine Slim both contain an undeclared ingredient -phenolphthalein

Mar 4        Public Notification: Botanical Slimming (Red) contains Fluoxetine  which is an FDA approved drug in a class of drugs called selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD).   Uses of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur.

Mar 4        Public Notification: Lean Body contains sibutramine, desmethyl sibutramine, phenolphthalein and sildenafil.

Mar 2        Guidance Agenda: New and Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2015.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 2        FDA is Announcing the 2015 REdl: Generic Drugs Forum.  This will take our previous GDUFA and You conference to a new level by expanding our content to other regulatory aspects that concern the generic drug industry.  April 22-23, 2015, The Sheraton Silver Spring Hotel, Silver Spring, MD.  This two-day conference offers you the opportunity to interact with FDA subject matter experts as we discuss various topics along the dynamic continuum of the generic drug approval process. This forum will be delivered in a hybrid format (you can attend virtually or in person).  Topics include:  Current Regulatory Practice in Type II API DMF Review, Update on Question-based Review (QbR), and Proper Regulatory Submission During the Lifecycle of Generic Drug Products.  This event is FREE, but you must register at:  http://sbiaevents.com/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 26      Drug Information Update - FDA approves new antibacterial drug Avycaz.  The U.S. Food and Drug Administration, on February 25, 2015, approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.  

Feb 19       Pharmacy Compounding Guidance

1.      Draft Guidance for Industry - Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for outsourcing facilities. Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434188.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

2.      Draft Guidance for Industry - Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  This draft guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434171.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3.      Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the States and the Food and Drug Administration; New Proposed Draft.  FDA is announcing the availability for public comment of a draft standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products between the State of [insert State] and the U.S. Food and Drug Administration.” The draft standard MOU describes the responsibilities of the State that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded human drug products.  Obtain more information at:  https://www.federalregister.gov/articles/2015/02/19/2015-03420/memorandum-of-understanding-addressing-certain-distributions-of-compounded-human-drug-products?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=govdelivery

4.      Draft Guidance for Industry - Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities. This guidance describes the conditions under which FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility repackages human drug products.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm434174.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Feb 19       Draft Guidance for Industry - Alcoholism: Developing Drugs for Treatment.  The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism.  Download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm433618.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 19     Guidance for Industry - Complicated Urinary Tract Infections: Developing Drugs for Treatment.  The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). This guidance finalizes the revised draft guidance of the same name issued on February 24, 2012. Get your copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070981.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 17       Drug Information Update - FDA approves Lenvima for a type of thyroid cancer.  The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).  The most common type of thyroid cancer, DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.

Feb 9         Detox Transforms Health and Nutrition Issues Voluntary Nationwide Recall of Dietary Supplements Due to the Presence of Undeclared Drug Ingredients.  Detox Transforms Health and Nutrition, Garner, NC announced it is conducting a voluntary recall of the following dietary supplements, to the consumer level, because they contain undeclared drug ingredients making them unapproved drugs. FDA analysis found iNDiGO and BtRim Max to contain undeclared phenolphthalein. 

Feb 9        FDA issues revised Draft Guidance for Industry on Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.  Download your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM069984.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery  

Feb 6         Guidance:  Individual Patient Expanded Access Applications Form FDA 3926.   Expanded access requests are sometimes referred to as compassionate use 22 requests. Individual patient expanded access allows for the use of an investigational drug outside 23 of a clinical investigation for an individual patient who has a serious or immediately life­ 24 threatening disease or condition and there is no comparable or satisfactory alternative therapy to 25 diagnose, monitor, or treat the disease or condition.  Get your copy at:   http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm432717.pdf

Feb 4         Drug Information Update- FDA approves Ibrance for postmenopausal women with advanced    breast cancer.  Breast cancer in women is the second most common type of cancer in the United States. It forms in the breast tissue and in advanced cases, spreads to surrounding normal tissue. The National Cancer Institute estimates that 232,670 American women were diagnosed with breast cancer and 40,000 died from the disease in 2014.  Ibrance works by inhibiting molecules, known as cyclin-dependent kinases (CDKs) 4 and 6, involved in promoting the growth of cancer cells.

February Warning Letters

                  Cadila Pharmaceuticals Limited, Gujarat, India   CGMP violations causing their Active   Pharmaceutical Ingredients (APIs) to be adulterated.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421544.htm

                  Novacyl (Thailand) Ltd., Samutprakam Thailand.  CGMP violations causing their APIs to be adulterated.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436268.htm  

                  Infiniti Creations, Inc., Lindon, UT 84042   Products marketed in violation of the FD&C Act.     Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436079.htm

                  Modern Herb Shop, Inc.  Sacramento, CA 95667  Products promoted for conditions that cause them to be new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436074.htm

                  Nutreglo Products, Inc. Miramar, FL 33029   Products promoted for conditions that cause them to be        new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435680.htm

                  Twin Falls Bio Tech, LLC, Hilton Head Island, SC 29926 Products promoted for conditions that cause them to be new drugs.  Download at:   Products promoted for conditions that cause them to be        new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435777.htm

                  MyNicNaxs, Inc., Deltona, FL 32725.  Products containing unapproved and undeclared drugs.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436724.htm

                  Better Health Lab, Inc., Hackensack, NJ 07601.     Marketing unapproved new drugs and adulterated and misbranded dietary supplements.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435044.htm

                  StriVectin Operating Company, New York, NY 10001.       Products promoted for conditions that cause them to be new drugs.  Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm436692.htm

                  A2Z Industries, LLC, Sherman Oaks, CA 91423.   Marketing unapproved new drugs and adulterated and misbranded dietary supplements.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm433809.htm  

                  LCW, Inc., dba uFresh Center and LDF Leaders Maker, San Gabriel, CA 91776  Marketing unapproved new drugs.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm435065.htm

Jan 30       Drug Information Update- FDA’s investigation into patients being injected with simulated IV fluids continues.  FDA first became of aware of adverse events at two clinics associated with the mistaken administration of Wallcur’s simulated Practi-0.9% sodium chloride IV in late December and issued a warning to all health care providers not to inject these simulated products in humans or animals on December 30, 2014.  Since then FDA and CDC took a number of steps to remove the simulated saline products from medical settings, raise awareness among health care providers, and provide information to state and local health officials in order to prevent exposure to additional patients.

Jan 30      Drug Information Update - FDA expands uses of Vyvanse to treat binge-eating disorder.  The drug is the first FDA-approved medication to treat this condition.  In binge-eating disorder, patients have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control

Jan 29      Updated Form 2252 along with newly created instructions.  Updates include new expiration date and Field 9b (distribution data)  Download the form at:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083558.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                                                    Download the instructions at:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM431287.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 28       Draft Guidance for Industry: Evaluating Drug Effects on the Ability To Operate a Motor Vehicle.  The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle.   Get your copy at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm430374.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Jan 28         Draft Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products.  This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products.  Available at:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf 

Jan 28       Proposed Rule: Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products.  FDA is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.

Jan 26       The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD).  Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion.  Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has gained approval to market esomeprazole in 20 and 40 milligram capsules. 

Jan 22   CDER Small Business Chronicles:  Drugs in Pregnancy and Lactation - Improved Risk Benefit Information.  Included is a discussion of the Pregnancy and Lactation Labeling Rule (PLLR) which sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.  Download your copy today at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM431132.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Jan 14       Recalls – Class II                                                                                                                                                    Gabapentin Capsules, USP, 400 mg, 300 mg, and 100 mg Rx Only, Manufactured by: Actavis Pharma Manufacturing Pvt. Ltd., Tamlinadu, India.   Distributed by: Actavis Elizabeth LLC, 700 Elmora Ave, Elizabeth, NJ 07207 USA.   Reason:  Failed Capsule/Tablet Specifications: Actavis has received several complaints for clumping and breaking of capsules with some bottles showing popped out bottle bottom (round bottom) and creased labels from one distribution center.

                  HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977 Reason:  Presence of Foreign Substance: Par Pharmaceutical, Inc. is recalling one lot of HydrALAZINE Hydrochloride tablets (38,788 bottles) due to the presence of small aluminum particles.

Jan 14       Recalls – Class III

                  Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).  Recalling Firm Akorn, Inc. Lake Forest IL.   Reason:  Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.

                  Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, and b) one pint (473 mL) bottles, Rx only.   Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811.   Reason:  Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.

Jan 8         Drug Information Update- FDA approves anti-clotting drug Savaysa.  The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.  Savaysa also has been approved to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have already been treated with an anti-clotting drug administered by injection or infusion (parenterally), for five to ten days.  DVT is a blood clot that forms in a vein deep in the body, usually in the lower leg or thigh. A potentially deadly condition called PE results when a blood clot in a deep vein breaks off and travels to an artery in the lungs and blocks blood flow.  

Jan 7         Recalls – Class II

                  GINSENG KIANPI PIL, 60 capsules, Product of Kweilin Drug Manufactory.  Recalling Firm: One and Zen, Albuquerque, NM.  Reason:  Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

                  Entertainer's Secret Throat Relief, 2.0 FL oz. (59.2 mL), Honey Apple Flavor, KLI Corp, Carmel, IN.  Recalling Firm: Tropichem Research Labs, Inc. Jupiter, Florida.  Reason:  Microbial Contamination of Non Sterile Product; microbial assay reported unacceptable high plate counts and positive for E. Coli.

Jan 2         Warning Letters

                  Apotex, Inc. Toronto, ON, Canada M9L 1 T9.   Significant violations of current Good Manufacturing Practice (cGMP) regulations (laboratory records, unauthorized changes to manufacturing records, lack of procedures to prevent microbiological contamination, and QC Unit failure to review and approve drug product control records).

                  Micro Labs Limited, Bangalore 560 001 India.  Significant violations of current Good Manufacturing Practice (cGMP) regulations

                  Aloe Man, Inc. Atlanta, GA 30311.  Unapproved new drugs adulterated and misbranded dietary supplements.

                  Complete H2O Minerals, West Columbia, SC 29169.  Unapproved drugs, misbranded drugs, adulterated and misbranded dietary supplements.

 Dec 31     Draft Guidance – DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.   Download at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm426126.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 31    Guidance for Industry – DSCSA Implementation:  Product Tracing Requirements – Compliance Policy.  Get your copy at:  http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm427867.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery.                                                                                                                                                            Note: on December 24 the FDA posted this guidance to inform industry that they do not intend to take action against manufacturers, wholesale distributors, or repackagers who do not, prior to May 1, 2015, provide or capture the product tracing information required by sections 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This action is to minimize possible disruptions in the distribution of prescription drugs in the United States.   For more information, please visit the FDA  “Are you ready for the Drug Supply Chain Security Act” web page, which contains an industry-focused checklist, links and descriptions for each of the DSCSA requirements which go in to effect on Jan. 1, 2015. 

Dec 31      Recalls – Class I

                  MAXI GOLD WEIGHT LOSS PILL, bottle contains 30 CAPSULES, product is packaged in a clear plastic bottle with blue lid, gold and orange label with orange font.                                                                                                                                                                                             SUPER FAT BURNER, bottle contains 30 CAPSULES, product is packaged in a white plastic bottle with black, red and green font.                                                                                                                                                                ESESMERALDA, bottle contains 30 Softgels, product is packaged in a white plastic bottle with green labeling and black font.   Distributed by: New Life nutritional, New York, NY, www.newlifenutritional.com under the following telephone numbers: (212) 923-6386, (212) 304-8880, (718) 329-1636 and (862) 591-2188.   Reason:  Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling Super Fat Burner, Maxi Gold Weight Loss Pill and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.

Dec 24    Recalls – Class II

                  Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21  Reason:  Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

                  Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA.  Reason:  Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.

Dec 23      Drug Information Update - FDA approves weight-management drug Saxenda.  This drug Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.  The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).

Dec 23      Warning Letters

                  Nutri Spec, Inc., Miffintown, PA   Dietary Supplement Violations at both their Miffintown and Indiana facilities as well as Misbranded Dietary Supplements.   Download at:   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm428827.htm,

Dec 22      Drug Information Update - FDA approves Opdivo for advanced melanoma.  Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. 

Dec 22      Drug Information Update - FDA approves Rapivab to treat flu infection.  Rapivab is an inhibitor of influenza virus neuraminidase, an enzyme that releases viral particles from infected cells. Neuraminidase inhibitors are commonly used to treat flu infection. Rapivab is the first neuraminidase inhibitor approved for intravenous (IV) administration and is administered as a single IV dose. It is intended for patients 18 years and older who have acute uncomplicated influenza and have shown symptoms of flu for no more than two days. 

Dec 22       Drug Information Update - FDA approves new antibacterial drug Zerbaxa.  The U.S. Food and Drug Administration approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cU, , , TI).  Zerbaxa is a combination product containing ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor. Zerbaxa is used to treat cUTI, including kidney infection (pyelonephritis). It is used in combination with metronidazole to treat cIAI.  Zerbaxa is the fourth new antibacterial drug approved by the FDA this year. The agency approved Dalvance (dalbavancin) in May, Sivextro (tedizolid) in June and Orbactiv (oritavancin) in August.

Dec 22      Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of SLIM-K Capsules Due to Undeclared Drug Ingredients.  Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of SLIM-K collected and tested by the FDA was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.  withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.

Dec 22      Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of B-Lipo Capsules Due to the Presence of an Undeclared Drug Ingredient.  Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain Lorcaserin, a controlled substance used for weight loss.

Dec 19      Drug Information Update- FDA approves Viekira Pak to treat hepatitis C.  The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.  Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Dec 19      Warning Letters

                  Novacyl Wuxi Pharmaceutical Co., Ltd, Wuxi Jiangsu 212185, China.  CGMP violations causing their APIs to be adulterated, as well as significant cGMP violations during manufacture of finished pharmaceuticals.  Download at:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm427976.htm  

Dec 19      Drug Information Update- FDA approves Lynparza to treat advanced ovarian cancer.  The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.   Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.

Dec 17       Drug Information Update- FDA approves Xtoro to treat swimmer’s ear.  Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is the newest drug belonging to the fluoroquinolone antimicrobial drug class to be approved by the FDA. It joins several other antibacterial drug products previously approved to treat ear infections.

Dec 17      Recalls – Class III

                  Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx only, 100 Capsules.   Manufacturer: Sandoz Inc., Princeton, NJ 08540 NDC 0781-2822-01.  Reason:  Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Specialty Pharma Newsletter (November-December 2014) 

Dec 17    Tristar Equine Issues Voluntary Recall of Gastrotec.   Gastrotec marketed by Tristar as an OTC drug for use in horses contains a combination of omeprazole and misoprostol. This recall has been initiated due to information from the FDA that Gastrotec must have an approved new animal drug application to be legally marketed in the United States. Gastrotec is not approved by the FDA. As a consequence, Tristar has ceased all production and sales of Gastrotec and is recalling the product.

Dec 17   Guidance for Industry (To be published December 18) Providing Regulatory Submissions in Electronic Format--Standardized Study Data.  You can download your unpublished copy at: CLICK TO DOWNLOAD 

Providing Regulatory Submissions in Electronic Format--Submissions under the Federal Food, Drug, and Cosmetic Act.  You can download your unpublished copy at:    CLICK TO DOWNLOAD 

Dec 17    CDER SBIA Webinar:  Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers.  

CDER SBIA is making available its accompanying pre-recorded webinar which: - provides an overview of the reporting requirements for wholesale distributors and third-party    logistics providers under DSCSA

     - describes who must report to FDA,

     - what information should be submitted to FDA,

     - the timing of the submissions,

     - a preferred format for the submissions, and

     - a preferred method for reporting to FDA.

You can download the webinar, presentation slides, and the Federal Registrar notice at: DOWNLOAD

Dec 16    Drug Shortage – Methylphenidate Hydrochloride ER Capsules and Tablets.  This product’s therapeutic categories are pediatric and psychiatry.

Dec 12    Drug Information Update- FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer.   The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).   The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. The National Cancer Institute estimates that 224,210 Americans will be diagnosed and 159,260 will die from lung cancer in 2014.   Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.

Dec 11    Slide Presentation at FDA/CMS Summit: CDER New Drug Review 2014 Update.   View at:  CLICK TO VIEW

Although the new molecular entity program is “running smoothly”, the FDA is still having issues with recruitment and retention of staff.

Dec 10    Recalls – Drugs Class III

BENZONATATE Capsules, USP, 200 mg, 100 Capsule Bottles, Rx only.   Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA, Inc.   Reason:  Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules. 

Dec 10    Mental Health Drug Ziprasidone (Geodon) Associated With Rare But Potentially Fatal Skin Reactions.  Ziprasidone is an antipsychotic drug used to treat the serious mental health disorders schizophrenia and bipolar I disorder.   Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS (Drug Reaction with Eosinophilia and Systemic Symptomsis) suspected.   DRESS can lead to death.

Dec 10    Guidance for Industry

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products – Content and Format.
Download at:  CLICK TO DOWNLOAD 

Draft - DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third Party Logistics Providers.  CDER Small Business and Industry Assistance will produce a webinar covering this guidance and annual reporting requirements on December 16, 2014. The webinar will be available via the CDER SBIA web page (view webpage)   

Download your copy of the Draft Guidance at:CLICK TO DOWNLOAD

Draft – General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.  
Download at: CLICK TO DOWNLOAD

Dec 10    Warning Letters – Starkist (For what it is worth: Nancy Pelosi’s husband Paul is purported to be a major stockholder in Starkist).  You can download a copy of the warning letter at:   CLICK TO DOWNLOAD

Dec 5      New USP Salt Policy   United States Pharmacopeia’s Monograph Naming Policy for Labeling of Salt Drug Substances in Drug Products and Compounded Preparations is discussed in this video.  Watch at:  CLICK TO WATCH

Dec 4      Guidance for Industry

Draft -  How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategy (REMS) for Reference Listed Drug (RLD).  This guidance is part of FDA’s efforts to assist in certain circumstances where brand-name drug companies refuse to sell to prospective ANDA sponsors supplies of reference listed drugs.
Download at:  CLICK TO DOWNLOAD                 

Draft - Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format.  You can read the Federal Register Notice at: CLICK TO READ

Dec 4      Drug Information Update - FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia.  Precursor B-cell ALL is a rapidly growing type of cancer in which the bone marrow makes too many B-cell lymphoblasts, an immature type of white blood cell. The Philadelphia chromosome is an abnormality that sometimes occurs in the bone marrow cells of leukemia patients. The National Cancer Institute estimates that 6,020 Americans will be diagnosed with ALL and 1,440 will die from the disease in 2014.   Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. 

Dec 2      Recalls – Drugs Class II   

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only.  Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 for Actavis Laboratories.   Reason:  Failed Tablet/Capsule Specifications: Presence of split or broken tablets.       

Dec 1      Guidance for Industry

Draft Guidance: Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.
Download at:  CLICK TO DOWNLOAD

The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.
Download at:  CLICK TO DOWNLOAD 

Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.  
Download at:  CLICK TO DOWNLOAD

Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act. 
Download at:  CLICK TO DOWNLOAD

Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (DRAFT).  
Download at: CLICK TO DOWNLOAD

Nov 21   Public Notifications - Products Containing Hidden Drug Ingredient

                   Super Extreme Accelerator for weight loss.   Hidden ingredient: Sibutramine

                   Bee Thin for weight loss.  Hidden ingredient:  Sibutramine

                   Black Storm for sexual enhancement.   Hidden ingredient:  Sildenafil

                   Be Slim for weight loss.   Hidden ingredient:  Sibutramine   

                   Feng Shi Ling for arthritic pain with rheumatoid arthritis & osteoporosis. 

                                Hidden ingredients: Diclofenac &  Indomethacin.

                    Forever Beautiful Bee Pollen   No specific indication.  Hidden ingredients:  Sibutramine & Phenolphthalein  

Nov 21   FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties.   The U.S. Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.  The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel (thick gel) and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.  Hysingla ER is not approved for, and should not be used for, as-needed pain relief.

Nov 19   Recalls – Drugs Class III

Simvastatin Tablets, USP, 10 mg, 90 count bottles, Rx Only.    Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90.  Reason:  Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification. 

Nov 19   Recalls – Drugs Class II

Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle.   Repackaged by Contract Packaging Resources, Inc. 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc., Chesapeake, VA 23320.   Reason:  Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into boxes of Assured Naproxen Sodium Tablets, USP

FLUOCINONIDE GEL USP, 0.05%, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, Rx only.  E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g).  Reason:  Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>. 

Nov 19   Guidance for Industry

Vaginal Microbicides:  Development for the Prevention of HIV Infection.   Download your copy at:  CLICK TO DOWNLOAD 

Rare Pediatric Disease Priority Review Vouchers, DRAFT.  Download your copy at:  CLICK TO DOWNLOAD

Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.  Download your copy at:  CLICK TO DOWNLOAD

Nov 19   Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, FDA White Oak Campus, Bldg. 31 The Great Room 1503A Silver Spring, MD.    If you are interested in obtaining input on the impact of chagas disease on daily life and patients’ views on currently available therapies to treat the condition.    For meeting information go to:   CLICK FOR MEETING INFORMATION           

Nov 19    FDA Requesting Comment on Proposed Criteria for “First Generic” Submissions.  FDA is opening a public docket and requesting comments on proposed criteria for “first generic” abbreviated new drug application (ANDA) submissions.  Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made pursuant to GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of “first generic” submissions.  FDA believes that these proposed criteria appropriately focus FDA’s resources on approving new safe and effective generic drug products for patient use as quickly as possible.  For more information and the latest events regarding GDUFA, please visit the Generic Drug User Fee Amendments of 2012 website.   Go to:  CLICK TO GO TO WEBSITE

Nov 18   FDA/CDER Small Business Chronicles November 18 Issue Discusses the “Purple Book”.  You can read it at:  CLICK TO READ 

Nov 18   Orange Book

Additions and Deletions.
Download at:  CLICK TO DOWNLOAD

Cumulative Supplement November 2014.
Download at:  CLICK TO DOWNLOAD

Nov 13   FDA Has Concerns About the Therapeutic Equivalence of two Generic Versions of Concerta Tablets (methylphenidate hydrochloride extended-release).   An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.  In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.  Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.  You can read the current guidance on this subject at:  CLICK TO READ 

Nov 12   Recalls – Class III

TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only.   Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent MADE IN ITALY; NDC 0008-1179-01.   Reason:  Crystallization: Impurities in a raw material used to manufacture the diluent can cause the formation of crystals in the diluent vials after cold storage. The TORISEL vials are not affected by this issue.

Candesartan Cilexetil Tablets, 4 mg, 8 mg, 16 mg, and 32 mg, 30-count bottles, Rx Only.   Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, INDIA, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3.  Reason:  Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Specialty Pharma Newsletter (October-November 2014)

Nov 10   Guidance for Industry - Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration  Download your copy at:  CLICK TO DOWNLOAD  

Nov 6     Recalls – Class I

All products, Rx Only  Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613.  Reason:  Lack of assurance of sterility. 

Nov 6     Recalls – Class II

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Weight 16 fl. oz. (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Weight 16 fl. oz. (473 mL), NDC 10702-052-16, Rx Only.   Manufactured for: KVK-TECH, INC. NEWTOWN, PA 18940, MADE IN USA, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.  Reason:  Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.   

Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.    Compounded by:   Martin Avenue Pharmacy, 1247 Rickert Drive, Naperville, IL.   Reason:  Lack of assurance of Sterility. 

Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc., Parsippany, NJ 07054 USA   Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4.    Reason:  Subpotent Drug 

Nov 4     Public Notification: V26 Slimming Coffee Contains Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use V26 Slimming Coffee, a product promoted and sold for weight loss on various websites and possibly in some retail stores.  FDA laboratory analysis confirmed that V26 Slimming Coffee contains sibutramine.  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.

Nov 5     Warning Letters

Issued to Hikma Pharmaceuticals, Ltd., Ammam, Jordan

Reason: cGMP violations 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 is a lack of investigations of unexplained discrepancies, and a failure to establish adequate written procedures for production and process control.

Issued to Vitamins Direct (USA), Inc & Golden Pride, Inc. 2540 Metrocentre Blvd, Suite 5 West Palm Beach, FL 33407    

Reason:  Your website promotes products for conditions that cause the products to be drugs under section 201(g) (1) (B) of the Federal Food, Drug, and Cosmetic Act.

Issued to Health Research Laboratories, LLC/New World Health, 433 E Las Colinas Blvd., Suite 1290, Irving, TX 75039   

Reason:  Your website promotes products for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act.

Oct 31    The Food and Drug Administration is advising consumers not to purchase or use “Ginseng Kianpi Pil,” a product promoted to stimulate appetite, promote weight gain and relieve fatigue, because it contains an undeclared corticosteroid and an antihistamine.  “Ginseng Kianpi Pil” is manufactured by Kweilin Drug Manufactory, and sold in retail stores and on various websites.  FDA laboratory analysis found that “Ginseng Kianpi Pil” contains dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment.

Oct 30    Drug Quality Sampling and Testing Programs.    Every year, FDA monitors and tests hundreds of drug products and active pharmaceutical ingredients to help ensure safe, effective and high-quality products are available to consumers.  FDA has posted details of our postmarket drug quality sampling and testing programs to provide product safety and effectiveness test results to health care professionals and consumers.  To learn more about FDA’s efforts to help ensure the regulatory standards for brand name and generic drugs continue to be met throughout a product’s lifecycle, visit the following webpage;   CLICK TO VISIT WEBPAGE

Oct 30    Request for Comments   FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in draft guidance for industry and review staff.   To learn more go to:  CLICK TO LEARN MORE  

Oct 30    Guidance for Industry - Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.  The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Download at:  CLICK TO DOWNLOAD

Oct 30    Draft Guidance for Industry – Migraine: Developing Drugs for Acute Treatment.   The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine.  Download a copy at:  CLICK TO DOWNLOAD 

Oct 29    Recalls – Class II

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only.   Packaged by Aidarex Pharmaceuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India   Reason:  Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg.

CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM, CHERRY AND GRAPE FLAVORS,, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL).  Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, Reason : OTC  Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.  

Numerous lotions, ointments & an expectorant OTC products  Manufactured by NEW GPC INC., A1 Farm, EBD Country of Origin: Guyana.  Reason:  Does Not Meet Monograph: NEW GPC INC. has recalled multiple Over-the-Counter Drug Products due to lack of drug listing, lack of OTC drug labeling requirements & labeled Not Approved for sale in USA.

MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters    Packaged and distributed by: American Health Packaging, Columbus, OH - Carton of 100 NDC 68084-149-01, Individual Dose NDC 68084-149-11.  Reason:  Subpotent; 6 month stability time point. 

ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC     Manufactured for ZEE Medical Inc., Irvine, CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528  Reason:  Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label. 

Oct 29    Drug Discontinuation – Namenda (Memantine Hydrochloride)  The sale of Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA 21-487 indicated for the treatment of moderate to severe dementia of the Alzheimer's type will be discontinued Fall of 2014. The product discontinuation is not related to product safety or efficacy. 

 

Oct 28    CDER List of Guidance Documents    Download your copy at:  CLICK TO DOWNLOAD

Oct 28    CDER Guidance New/Revised/Withdrawn    A copy can be found at:   CLICK TO VIEW COPY

Oct 27    The U.S. Food and Drug Administration on Oct 23, 2014 approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).  Unlike inherited hemophilia, acquired hemophilia A is not a genetic disorder and affects both males and females. The development of acquired hemophilia A has been related to other medical conditions or health states, such as pregnancy, cancer, or the use of certain medications. However, in about half of the cases, no underlying cause can be found. Diagnosis of this condition can be difficult and the severity of the bleeding can make treatment challenging.  Obizur contains a recombinant analogue of porcine (pig) FVIII. Porcine FVIII is used because it is similar enough to human FVIII to be effective in blood clotting, but is less likely to be affected by the antibodies against human FVIII that are present in people with acquired hemophilia A.

Oct 27    Nutek Disposables, Inc. Issues Alert Due to Potential Bacteria in Baby Wipes.  Nutek Disposables, Inc. of McElhattan, PA has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties, Diapers.com, Femtex, Fred's, Kidgets, Member's Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria.

Oct 23    Contract Packaging Resources, Inc. Issues a Voluntary Nationwide Recall of Assured™ Brand Naproxen Sodium Tablets due to Packaging Mix-Up.  Greensboro, N.C., Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured™ brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The Ibuprofen bottles were placed in the Naproxen Sodium boxes due to a packaging error. The affected products are: boxes of Assured™ brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength.

Oct 22    Recalls – Class III

Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles  Manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada  Reason:  Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset.       

Vasotec (enalapril maleate) tablets, RX only.   Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada     Reason:  Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. 

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. and Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S., and Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S, Clonidine HCL, 97 Kg, Rx Only, S.I.M.S.  Chemical Products for Medicines Preparation - Made in Italy.   Reason:  cGMP Deviations: GYMA laboratories of America, Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices. 

Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only     Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220.  Reason:  Subpotent Drug; for the active, HCB, and preservatives, propylparaben and butylparaben at the 18 month stability test point. 

TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only.  

Manufactured by Cadila Healthcare Ltd., Ahmedabad, India  

Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534     Reason:  Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets. 

Oct 17  Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit.  Hospira has initiated an investigation to determine the root cause & corrective & preventive actions.   

Oct 17    FDA approves labeling with abuse-deterrent properties for Embeda, an extended-release opioid analgesic.   FDA approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Abuse-Deterrent Opioids – Evaluation and Labeling”.  The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral and intranasal abuse when the product is crushed.

Oct 17    The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).  Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.  The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product’s prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.

Oct 16    Draft Guidance for Industry: The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.   FDA has announced the availability of a draft guidance for industry titled: “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers.”  FDA is issuing this guidance to assist stakeholders in understanding the effects of section 585 (Uniform National Policy) of the Food Drug and Cosmetic Act, which was added by the Drug Supply Chain Security Act (DSCSA).  The DSCSA establishes a Federal system for tracing prescription drug products through the pharmaceutical distribution supply chain. It also requires FDA to establish federal standards for licensing of wholesale drug distributors and third party logistics providers.  Download the Draft Guidance at:  CLICK TO DOWNLOAD 

Find more information on DSCSA at:  CLICK FOR MORE INFORMATION

Oct 16   Draft Guidance for Industry: Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen.   This draft guidance is intended to help drug manufacturers, packagers, and labelers minimize the risk to consumers of acetaminophen-related liver damage associated with the use of nonprescription, also known as over-the-counter (OTC), acetaminophen-containing pediatric liquid drug products. This guidance provides recommendations for acetaminophen concentration, container labels and carton labeling, packaging of such products, and recommendations regarding any associated delivery devices. FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion.   Get your copy at:  CLICK TO DOWNLOAD COPY

Oct 16    Draft Guidance for Industry:  New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.  This draft guidance sets forth a change in the Agency's interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). If the guidance is finalized, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of “new chemical entity,” regardless of whether that drug substance is approved alone or in certain fixed-combinations.
Download at:  CLICK TO DOWNLOAD

Oct 15    Recalls - Class II

Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only    Manufactured by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505.   Reason:   Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol. 

Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only   Manufactured for Mylan Institutional, LLC, Rockford, IL 61103.   Reason:  Temperature Abuse: One shipment was inadvertently stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.

Oct 10    The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.  Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.   Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir.

Oct 7      FDA is announcing the fee rate of $2,562,000 for using a rare pediatric disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees  for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the rare pediatric disease priority review fee rate for FY 2015 and outlines the payment procedures for such fees. 

Oct 7      Recalls – Class I

BLACK ANT, 2800 mg, four capsules per box, and MOJO RISEN, 650 mg, 2 capsules per pouch, and AFRICAN BLACK ANT, 2800 mg, 6 capsules per box.  Recalling Firm:  Eugene Oregon, Inc.  Reason: Marketed Without an Approved NDA/ANDA Eugene FDA laboratory analyses determined they contain undeclared sildenafil.

Oct 7      Guidance for Industry - Pathological Complete Response in Neoadjuvant (i.e. Preoperative) Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval   This guidance is intended to encourage industry innovation and expedite the development of breakthrough therapies to treat high-risk early-stage breast cancer. This guidance finalizes the draft guidance issued May 30, 2012.  
Download at:  CLICK TO DOWNLOAD

Oct 3      The U.S. Food and Drug Administration (FDA) has Published the Fiscal Year 2015 Regulatory Science Priorities for Generic Drugs. 

• Post-market evaluation of generic drugs
• Equivalence of complex products
• Equivalence of locally-acting products
• Therapeutic equivalence evaluation and standards
• Computational and analytical tools

Oct 1      Recalls – Class III

Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only    Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326.   Reason:  Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.   

Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr.), 1 patch per pouch, packaged in 30-count patches per box, Rx Only.  Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.   Reason:  Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.        

Oct 1      CDER Has Announced Another Web-based Course in its Small Business and Industry Education Series entitled, “Engaging With the FDA During New Drug Development”.  It is designed to help small pharmaceutical business communicate and interact with FDA.   Go to:  CLICK TO VIEW COURSE

Sep 30    Report on the Standardization of Risk Evaluation and Mitigation Strategies.  FDA is announcing the availability of a draft report entitled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)”. This report describes the Agency's findings concerning strategies to standardize risk evaluation and mitigation strategies (REMS), where appropriate, with the goal of reducing the burden of implementing REMS on practitioners, patients, and others in various health care settings. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into the existing and evolving health care system. FDA is publishing this report to allow the public to provide comment on the report as i, t relates to PDUFA.  Go here to read , the report:  CLICK TO READ REPORT 

Sep 24    Recalls – Class I

AFRICAN BLACK ANT, 2800 mg, 6 capsules per box and Black Ant, 4600 mg, four capsules per box, and XZEN GOLD, 750 mg, six capsules per bottle, and XZEN PLATINUM, 750 mg, 1 capsule per blister pack, and Xzone 1200, 750 mg, one capsule per blister pack, and XZONE GOLD, 750 mg, one capsule blister pack, and MOJO RISEN, 670 mg, 2 capsule per pouch. Produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City   Reason: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction. 

Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only   Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110.  Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.  Reason:  Failed Content Uniformity Specifications.

Sep 22    FDA approves Trulicity to treat Type Two Diabetes.  The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type two diabetes.  Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type two diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control.  Trulicity has a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies 

Sep 18    The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type two diabetes.  Type two diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type two diabetes received Trulicity. Patients receiving Trulicity, had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).  Trulicity has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Trulicity should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for patients who cannot be managed with diet and exercise. 

Sep 18    The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.  Opioids are a class of drugs that are used to treat and manage pain.  A common side effect associated with the use of these drugs are that they reduce the gastrointestinal tract’s motility, making bowel movements difficult and causing patients to strain, have hard or lumpy stools or experience a sensation of incomplete evacuation. Movantik belongs to a class of drugs called peripherally acting opioid receptor antagonists, which are used to decrease the constipating effects of opioids.  Movantik’s safety and effectiveness were established in two clinical trials of 1,352 participants who had taken opioids for at least four weeks for non-cancer related pain and had opioid-induced constipation. Participants were randomly assigned to receive 12.5 mg or 25 mg of Movantik or placebo (sugar pill) once daily for 12 weeks. The trials were designed to measure the change in the number of bowel movements per week from the start of the study.  Results of the first trial showed that 44 percent of participants receiving 25 mg of Movantik and 41 percent of participants receiving 12.5 mg of Movantik experienced an increase in bowel movements per week, compared to 29 percent of participants receiving placebo. The second trial showed similar results.  Common side effects of Movantik include abdominal pain, diarrhea, headache and the experience of excessive gas in the stomach or intestinal area (flatulence).

Sep 17    Recalls – Class III  CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml),OTC.  Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.   Reason:  Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

Sept 16   Guidance for Industry:

1)      ANDA Submissions – Refuse to Receive Standards.  This guidance assists applicants preparing to submit abbreviated new drug applications (ANDAs), and related submissions (i.e., prior approval supplements (PASs) for new strengths).  The guidance highlights serious deficiencies in the application ANDA or new strength PAS that may cause FDA to refuse-to-receive the submission.  Download here:  CLICK TO DOWNLOAD

2)      ANDA Submissions - Refuse to Receive for Lack of Proper Justification of Impurity Limits.

This guidance assists applicants preparing to submit to FDA ANDAs and prior approval supplements (PASs) to ANDAs, for which the applicant is seeking approval of a new strength of the drug product.  It highlights deficiencies in information about impurities that may cause FDA to refuse-to-receive an ANDA or new strength PAS. Download here:  CLICK TO DOWNLOAD

Specialty Pharma Newsletter -May-September 2014 

Sept 11   FDA approves weight-management drug Contrave.  The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.  The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

Sept 11   Small Business Chronicles: Registration and Drug Listing    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Who, What, When, and How of Registration and Drug Listing.  Obtain your copy at:   Registration and Drug Listing. 

Sept 12   Recalls – Class II

Paroxetine HCL Controlled-Release Tablets 10 mg, 12.5 mg, 20 mg, 25 mg, 37.5 mg, and 40 mg, 30-count bottles and Paxil Oral Suspension, Rx only.   Manufactured by GlaxoSmithKline, RTP, NC 27709, Manufactured for Apotex Corp., Weston, FL 33328.   Reason:  Chemical Contamination: Products were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents. 

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21.  Reason:  Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles. 

Sept 10   FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas.  The FDA has issued a formal request to Downing Labs (dba NuVision Pharmacy in Dallas) for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs’ Dallas facility. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of purportedly sterile drug products made at the Downing Labs facility.  Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death. 

Sept 10  FDA publishes Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.  The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).  The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product).

Sept 9     CDER SBIA Webinar on “How to use CDER Direct to submit Registration and Listing Structured Product Labeling (SPL) files” – September 16, 2014.  This webinar will provide a brief demo of CDER Direct, a new software application to assist companies in submitting drug registration and listing submissions.   To register for this Event, please go the following link:  CLICK HERE TO REGISTER  Registration password needs to be 8 characters and alphanumeric. 

Sept 8     Guidance Webinar Invitation: "Uncomplicated Gonorrhea: Developing Drugs for Treatment".  On Thursday, September 11, 2014, from 10:00 a.m. – 11:00 a.m. EDT, FDA will present a webinar on this draft guidance for industry.  The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs for the treatment of uncomplicated gonorrhea.  To access this webinar, click on the following access link:  CLICK TO ACCESS WEBINAR.   The full announcement of the Webinar is found here:   CLICK TO VIEW ANNOUNCEMENT   

Sept 5     Warning Letters

Issued to MicroTest, 104 Gold St, Agawam, MA 01001.  Reason: failure to pay the appropriate facility fee as required by GDUFA. Any drugs or active pharmaceutical ingredients (API) manufactured, prepared, propagated, compounded or processed at a facility for which required facility fees have not been paid or required self-identifying information has not been submitted, or drugs containing an active pharmaceutical ingredient manufactured, prepared, propagated, compounded or processed at such a facility are misbranded. Your facility has been placed on a publicly available GDUFA facility arrears list for failure to pay required fees in 2013 and 2014.  

Sept 5     Guidance for Industry:  Electronic Submission of Lot Distribution Reports (PDF-62KB).  You can download this guidance at:   Electronic Submission of Lot Distribution Reports (PDF - 62KB)

Sept 4      Drug Information Update- FDA approves Keytruda for advanced melanoma.  The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.  Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. 

Sept 3     Recalls – Class III 

Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only.  Manufactured by Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.  Reason:  Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing. 

Aug 26   FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development.   This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development.  This guidance also describes FDA’s process for providing communications related to such correspondence. A pre-recorded webinar explaining this draft guidance is available at :  CLICK TO VIEW WEBINAR   You can download this draft guidance at:    Controlled Correspondence Related to Generic Drug Development 

Aug 26   FDA’s new Web-based Learning Course “Human Drug Establishment Registration and Drug Listing Compliance” is available at:  CLICK TO VIEW   

Aug 20   Recalls – Class I

Super ARTHGOLD 500mg, 120 Capsule Bottles, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.  Reason:  Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone. 

Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption.  30 pills /Bottle, Distributed by: Bacai, Inc.   Reason:  Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.

Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only.   Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017 NDC 0009-3073-03 DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL, 1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer, Inc., New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23.  Reason:  Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0 

Aug 20  Drug Information Update - FDA approves new drug to treat a form of Gaucher disease.  The U.S. Food & Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.  Type 1 Gaucher disease is estimated to affect about 6,000 people in the US. 

Aug 19   FDA Public Workshop: Innovations in Breast Cancer Drug Development – Next Generation Oncology Trials, Breast Cancer Workshop.    It will be held on October 21, 2014, 8:00 AM to 5:00 PM at the Hyatt Regency Bethesda Hotel, One Bethesda Metro Center (7400 Wisconsin Avenue), Bethesda, MD 20814.  There is no registration fee for the public workshop, but for planning purposes, please register at the following site:  https://www.surveymonkey.com/s/BreastWorkshop2014  

Aug 19   Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format.  This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products.
You can download at:Guidance Document 

Aug 19   FDA Announces GDUFA Public Hearing on Policy Development.  It will be held September 17, 2014 from 9:00 AM to 5:00 PM at the College Park Marriott. 3501 University Blvd., East Hyattsville, MD 20783.   Public Hearing on Policy Development to solicit public comment on certain topics related to implementation of GDUFA and the GDUFA Commitment Letter that accompanies the legislation.  FDA wants your input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks your input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics.  Learn more at:  CLICK TO LEARN MORE

Aug 15   Drug Information Update - Turkish Man Pleads Guilty to Importing Illegal Cancer Drugs.   Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.  Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States. 

Aug 15   Drug Information Update - FDA warns consumers about fraudulent Ebola treatment products.   The U.S. Food and Drug Administration is advising consumers to be aware of products sold online claiming to prevent or treat the Ebola virus. Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection.  There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. 

Aug 15   Drug Information Update - FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer.  The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.  Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.   Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Aug 15   FDA Small Business & Industry Assistance Regulatory Education for Industry (REdI) Conference Fall 2014. This event is free. It will be held on September 18-19 at the Hyatt Regency Bethesda in Bethesda, MD. 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 & Research (CDER) & Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant & helpful information on the key aspects of drug & device regulations. Our primary audience is that of small manufacturers of drug &/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices. To register go to:     https://www.signup4.net/public/ap.aspx?EID=FDAS18E&OID=130   

Aug 14   Guidance for Industry - Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products – Considerations, Content, and Format.    You can download this guidance at: CLICK TO DOWNLOAD

Aug 14   Drug Information Update - FDA approves Belsomra (suvorexant) to treat insomnia.  The U.S. Food and Drug Administration on August 13, 2014 approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.  Belsomra should be taken no more than once per night, within 30 minutes of going to bed, with at least seven hours remaining before the planned time of waking. The total dose should not exceed 20 mg once daily.  The most commonly reported adverse reaction reported by clinical trial participants taking Belsomra was drowsiness. 

Aug 13   Recalls – Class III

Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only.  Manufactured by: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10.   Reason: Presence of Foreign Substance; tablets may contain stainless steel metal particulates. 

Aug 13   Recalls – Class II

All injectables sold by Medical Supply Liquidators, LLC., Clive, Iowa. Reason: Marketed without an Approved NDA/ANDA; IM & SQ injectable products are being recalled because the mnfg firm is not registered with the FDA as a drug manufacturer.

Numerous Durmamedics and Therametrics Skin Creams and Systems.   Distributed by Dermamedics, LLC. Oklahoma City, OK.   Reason:  Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Aug 7   Drug Information Update - FDA approves Orbactiv to treat skin infections.  The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.  Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.

Aug 6     Guidance for Industry – Upper Facial Lines: Developing Botulinum Toxin Drug Products.   You can download this guidance at:   CLICK TO DOWNLOAD 

Aug 5    Guidance for Industry – Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.  You can download this guidance at:  CLICK TO DOWNLOAD

Aug 1     Drug Information Update- FDA approves Jardiance to treat type 2 diabetes.    The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. 

Aug 1     FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates.   Today the U.S. Food and Drug Administration (FDA) published the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA).   For FY 2015, the generic drug fee rates are: ANDA ($58,730), PAS ($29,370), DMF ($26,720), domestic API facility ($41,926), foreign API facility ($56,926), domestic FDF facility ($247,717), and foreign FDF facility ($262,717). These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.   You can review the Federal Register Notice at:  the fiscal year 2015 generic drug user fee rates 

Jul 30 Recalls – Class I and II

Shamrock Medical Solutions Group LLC, Lewis Center, Ohio, has initiated recalls on its products due to labeling mix-ups where the product labeling is not correct for the product in the package.  Product labeling included in these recalls are:  Diltiazem HCl Capsules, Oxycodone HCL Oral Concentrate, Metformin ER Tablets, Pramipexole Dihydrochloride Tablets, Sulfamethoxazole and Trimethoprim Tablets, and Docusate Calcium Softgel Capsules.         

Franck’s Lab,Inc, dba Trinity Care Solutions, Ocala, FL has initiated a recall of 30 of its products because there is a lack of assurance of sterility. All lots of sterile products compounded by the pharmacy within exp are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Jul 30     Recalls – Class III  

Orphenadrine Citrate Extended Release Tablets, 100 mg a) 100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only.   Manufactured by Sandoz Inc., Princeton, NJ 08540.    Reason:  Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. 

Jul 29    FDA Listing of Authorized Generics as of Jul 29, 2014. Download list at: FDA Listing of Authorized Generic Drugs 

Jul 29    The Sixth Annual Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration’s Office of Medical Policy and the Duke University School of Medicine, is now open for registration.  This extensive 3-day course starting November 4, focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists, and other health care professionals involved in clinical trials- cost $150.   For information and how to register:  http://continuingeducation.dcri.duke.edu/CITC?source=govdelivery&utm_medium=email&utm_source=govdelivery   

Jul 28     Guidance for Industry – (Draft) Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.
Download at:   CLICK TO DOWNLOAD

Jul 25     FDA has published notices in the Federal Register announcing the availability of two draft guidance for industry:

1)    Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under   GDUFA

2)     Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA

Control/Click to follow the above links. 

Jul 25     Recalls – Class III

Teva Pharmaceuticals USA is recalling the following products due to failed impurities/degradation specifications:                Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only,                Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, sold by Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67 

Jul 24     FDA approves new extended-release oxycodone with abuse-deterrent properties. The U.S. Food & Drug Administration approved Targiniq ER (oxycodone hydrochloride & naloxone hydrochloride extended-release tablets) an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment & for which alternative treatment options are inadequate. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose. Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused. It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death. 

Jul 23    FDA approved Zydelig (idelalisib) for three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has returned or relapsed. Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. 

Jul 21     Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging.  American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016.

Jul 18     Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs  The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.     According to the indictment, as of July 2004, FedEx employees had identified over 200 accounts that were associated with online pharmacies. By September of 2010, the list had increased to over 600 online pharmacy accounts.

Jul 16    Voluntary Nationwide Recall of Tattoo Ink, Tattoo Needles, Tattoo kits due to Microbial contamination.  White & Blue Lion, Inc. in the City of Industry, CA is recalling all lots of tattoo Inks and tattoo needles due to pathogenic bacterial contamination. Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection. As of an extra precaution, we are also recalling all tubes and ink cups as well. The recall includes all tattoo ink, tattoo needles, tubes, ink cups distributed by White & Blue Lion.

July 11    Guidance for Industry – Draft - Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act    You can download a copy at:  CLICK TO DOWNLOAD

Jul 11    Dumb and Dumber - Charles Products Recalls Decorative Pint And Shot Glasses Due To Possible Health Risk.  Charles Products, Inc. (CPI) announced today that it is voluntarily recalling shot and pint glasses identified below sold exclusively through M&M’S World retail stores in New York, Las Vegas, Orlando and London.  The company became aware that the glassware may exceed the Food and Drug Administration’s (“FDA”) guidance levels for leachable lead and cadmium. Both lead and cadmium are heavy metals found in the environment that accumulate in human bodies. Both can cause serious health complications at high levels. These glasses should therefore be returned and should not be used for the consumption of beverages, alcoholic or otherwise. 

Jul 8      The Following Products have been cited by the FDA because they contain a Hidden Drug Ingredient (sibutramine or sildenafil): 

1)      Trim Fast Slimming Softgel

2)      Sliming (sic) Diet by Pretty White

3)      Lipo 8 Burin Slim Capsules

4)      24 Ince

5)      Lingzhi Cleansed Slim Tea

6)      Mix Fruit Slimming

7)      Gold Viagra

8)      Miraculous Evil Root

9)      Sport Burner

10)    Toxin Discharged Tea

11)    Burn 7 Capsules (also contain phenolphthalein)

12)    Gold Reallas (contains Thiosildenafil)

13)    Full Throttle On Demand (contains propoxyphenyl sildenafil)

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.  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 

Jul 8       Draft Guidance for Industry – Best Practices in Developing Proprietary Names for Drugs   You can download this guidance at:  Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs

Jul 8       Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period   FDA is reopening the comment period for the notice of public hearing, published in the Federal Register of February 24, 2014 (79 FR 10168), requesting comment on how to improve or alter the current Over-the-Counter (OTC) Monograph Process for reviewing nonprescription drugs marketed under the OTC Drug Review. FDA is reopening the comment period to update comments and to receive any new information.

Jul 3       FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma   The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.  PTCL comprises a diverse group of rare diseases in which lymph nodes become cancerous.

Jun 27   FDA Drug Safety Podcast: FDA adding general warning to testosterone products about potential for venous blood clots   On June 19, 2014, FDA announced it is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins, also known as venous thromboembolism, including deep vein thrombosis and pulmonary embolism. The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to the labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure that this risk is described consistently in the labeling of all approved testosterone products.  Go to this website to listen:  CLICK TO VIEW WEBSITE   

Jun 27    FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning    Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.  In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.  Recommended alternatives: Use a teething ring chilled in the refrigerator (not frozen), or gently rub or massage the child’s gums with your finger to relieve the symptoms. 

Jun 26       FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products   The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.  They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.

Based on the information reported to FDA, we cannot determine if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both.  The hypersensitivity reactions may occur within minutes to a day or longer after product use.   Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue; hives or itching. 

Jun 25    FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment  with intravenous chemotherapy drug, docetaxel, contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. 

Several forms of docetaxel are currently marketed including generics and the brand-name products Taxotere, Docefrez, and Docetaxel Injection. The various products contain different amounts of alcohol, which health care professionals should be aware of in order to monitor and counsel patients appropriately. 

Jun 24    Guidance for Industry – Drug Supply Chain Security Act Implementation: Identification of Suspect Product & Notification.  The Drug Supply Chain Security Act of 2013 requires FDA to issue draft guidance to help certain trading partners (manufacturers, repackagers, wholesale distributors & dispensers) identify suspect products & must begin notifying FDA if it suspects it has illegitimate product in its possession on Jan 15, 2015. This guidance also provides information for supply chain stakeholders about how to notify FDA when they determine that they have an illegitimate product, and how to terminate that notification, consulting with FDA, should it no longer be necessary.  You can download this guidance at:     Guidance for Industry - Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification 

Jun 13    Guidance for Industry: Q4B Annex 6: Uniformity of Dosage Units General Chapter   You can get your copy at:   Q4B Annex 6: Uniformity of Dosage Units General Chapter (PDF - 53KB) 

Jun 12    Guidance for Industry: ANDA Submissions--Content and Format of Abbreviated New Drug Applications 
Download at:    ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 215KB) 

Jun 9      Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices    You can receive a copy at:  CLICK TO VIEW COPY

Jun 4      Recalls – Class II

Cefpodoxime  Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Mnfd in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20. Reason:Presence of Particulate Matter: Presence of stainless steel particles.

May 30  The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.  Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.

May 29  Blog: FDA’s Final Guidance on Expedited Drug Approvals.  Read at:  http://blogs.fda.gov/fdavoice/index.php/2014/05/fdas-final-guidance-on-expedited-drug-approvals-fueling-innovation-and-helping-patients/?source=govdelivery&utm_medium=email&utm_source=govdelivery   

May 29  Guidance for Industry – Expedited Programs for Serious Conditions-Drugs & Biologics  
Download at:  Expedited Programs for Serious Conditions – Drugs and Biologics (PDF - 276KB) 

May 29 Guidance for Industry – Product Development Under the Animal Rule  
Download at:  Product Development Under the Animal Rule (PDF - 2MB) 

May 29  “JumpStarting” Drug Review    The JumpStart service is modernizing the drug review process—medical reviewers are using this service to quickly and thoroughly assess data from drug clinical trials, ensuring safe and effective products are approved for public use.  Read at:  CLICK TO READ 

May 23  The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.  Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

May 19  NIH:  Longevity Gene Linked to Better Brain Skills.  Read more at:  CLICK TO READ

May 19  2014 GDUFA and You Conference Slides Now Posted   The slides for the “GDUFA and You 2014 Conference” are now posted on our website at:  2014 GDUFA and You Conference Presentation Slides¹

May 15  FDA warns of next-day impairment with sleep aid Lunesta (eszopiclone) and lowers recommended dose   The U.S. Food and Drug Administration (FDA) is warning that the insomnia drug Lunesta (eszopiclone) can cause next-day impairment of driving and other activities that require alertness.  As a result, we have decreased the recommended starting dose of Lunesta to 1 mg at bedtime. 

May 15  FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin   FDA announced that in its ongoing review of the blood thinner Pradaxa (generic name dabigatran), FDA recently completed a new study in Medicare patients comparing Pradaxa to an older blood thinner, warfarin (Coumadin, Jantoven and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction, and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation.    Patients should not stop taking Pradaxa (or warfarin) without first talking to their health care professional. Stopping the use of blood-thinning medications such as Pradaxa and warfarin can increase the risk of stroke and lead to permanent disability and death.  

May 15  Small Business Chronicles: Drug Shortages – Make an Impact    The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Drug Shortages – Make an Impact  Obtain your copy at:     Drug Shortages 

May 14  Guidance for Industry:  ANDAs – Stability Testing of Drug Substances and Products Q&A  Download your copy at:   guidance document  

May 14   Guidance for Industry:  Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product   Download your copy at:   CLICK TO DOWNLOAD

May 5    Guidance for Industry: CMC Post-Approval Manufacturing Changes To Be Documented in Annual Reports 
Download at:  Guidance Document 

Apr 30    FDA approves Zykadia for late-stage lung cancer  The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).  Zykadia is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizo, tinib, the only other approved ALK tyrosine kinase inhibitor.

Apr 24   FDA approves Sylvant for rare Castleman’s disease  The U.S. Food & Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes).  MCD causes an abnormal overgrowth of immune cells in lymph nodes & related tissues in the body. The disease usually affects adults who often suffer from fever, night sweats, weight loss & weakness or fatigue because their body’s immune system is weakened & cannot fight infections.  Sylvant is an injection that works by blocking a protein that stimulates abnormal growth of immune cells. It is intended for patients with MCD who do not have HIV or human herpes virus 8 (HHV-8).

Apr 17 &nbs, p; FDA approves Ragwitek for short ragweed pollen  The U.S. Food & Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.  Ragwitek contains an extract from short ragweed (Ambrosia artemisiifolia) pollen. It is a tablet that is taken once daily by placing it sublingually, where it rapidly dissolves. Treatment with Ragwitek is started 12 weeks before the start of ra, ,, g, , , weed pollen season and continued throughout the season. The first dose is taken in a health care professional’s office where the patient is to be observed for at least 30 minutes for potential adverse reactions. After the first dose, patients can take Ragwitek at home. 

Apr 17  Guidance for Industry – Comprehensive List of Guidance Documents
Download at:  Comprehensive List of Guidance Documents (PDF - 846KB)

Apr 17   Guidance for Industry – Center for Drug Evaluation and Research List of Guidance Documents New/Revised/Withdrawn Jan 1 – June 30, 2014 
Download at:  New/Revised Withdrawn List for 2014 (PDF - 66KB)

Specialty Pharma Newsletter - January-April 2014 

Apr 16   FDA Webinar:  Draft Guidance for Industry - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.   On Wednesday, AOn Wednesday, April 23, 2014, from 1:00 p.m. – 2:00 p.m. EDT, FDA will present a webinar on the draft guidance for industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers. Webinar access link: https://collaboration.fda.gov/gfiwebinar 

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

To download the guidance, go to:  CLICK TO DOWNLOAD

 Apr 16   Warning Letters

Issued to Driven Sports, Inc., 672 Dogwood Avenue, Suite 329, Franklin Square, NY 11010.  Reason:  Their product CRAZE which is labeled as a dietary supplement, contains a new dietary ingredient which makes it adulterated under section 402(f) of the Act [21 U.S.C. 342b (a) (2) and 21CFR 190.6.

 Issued to Aloe Man International Corp., 18800 NW 2^nd Avenue, Suite 102, Miami, FL.  Reason: Their products Gap Pills, GAP Liquid, The Body Healer, The Big C, Super Cleanser, Maximum Desire, SOC, High Thyroid Regulator, and Low Thyroid Regulator are products 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 your labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 

Issued to Deseo Rebajar Inc., P.O. Box 7218, Humacao, PR 00792.  Reason:  Your products, "Adipotrim XT," "Burn 7," "Reductrol Fat Burner Formula," ''Adipocleanse," "Adipocleanse XT," "Lipozene," and "Slim Patch" are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§355(a) and 331(d)] and are misbranded drugs sold in violation of sections 502 and 301(a) of the FDCA [21 U.S.C. §§ 352 and 331(a)] 

Apr 15   Drug Information Update – FDA Approves Tanzeum to Treat Type 2 Diabetes  The U.S. Food & Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control along with diet & exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety & effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

Apr 11   FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  In Aug 2012 FDA added the warning “use of Revatio, particularly chronic use, is not recommended in children” to Revatio’s drug label. A FDA Drug Safety Communication was also issued.  This recommendation was based on clinical trial results showing a higher mortality risk in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose.

Apr 11   The products “Infinity” and “Lite Fit USA” Contain a Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use Infinity or Lite Fit USA, products promoted and sold for weight loss on various websites, and in some retail stores.  FDA laboratory analysis confirmed that Infinity contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. 

Apr 10   Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act.  This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities (outsourcing facility) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.
Download at:  CLICK TO DOWNLOAD

Apr 9     Guidance for Industry:  Immunogenicity-Related Considerations for Approval of Low Molecular Weight Heparin for NDAs and ANDAs.  
You can download at:  CLICK TO DOWNLOAD

Apr 9     Recalls – Drugs Class III

Tivicay (dolutegravir) Tablets 50 mg, 30 Tablet Bottles, Rx Only.   Manufactured for: ViiV Health, TRP, NC 27709; by: GlaxoSmithKline, Research Triangle Park, NC 27709. Made in Japan. NDC 49702-228-13.  Reason:  Cross Contamination with Other Products: Product contains Promecta (eltrombopag).

Recalls – Drugs Class II

Duloxetine Delayed-Release Capsules, USP, 20 mg, 30 mg, and 60 mg, Rx Only, 60 capsules per Bottle.   Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7542-06.  Reason:   Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.

HydrOXYzine HCl Tablets, USP 25 mg and 50 mg, 100 Tablet Blister, Rx only.   Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01.  Reason:  Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Apr 7     The U.S. Food & Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss & body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the USt. All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the following undeclared drug ingredients:  Sibutramine – a controlled substance that was removed 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.   Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

Apr 3     Public Workshop:  Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format.  FDA will hold the public workshop May 8-9, 2014, at FDA’s White Oak campus in Silver Spring, MD.  You must register by April 24, 2014.  Registration is free. Seats are limited. For more information and registration instructions, please visit:  http://www.fda.gov/Drugs/NewsEvents/ucm388993.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Send questions to:         

Apr 2    Public Notification: New You Contains Hidden Drug Ingredients: Sibutramine and Phenolphthalein.  Note: This notification is to inform the public of a growing trend of 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.”   

Mar 31   Drug Information Update - FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension.  FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with pulmonary arterial hypertension. 

Mar 31   FDA warns consumers not to purchase or use weight loss product Alli.  The U.S. Food and Drug Administration is alerting consumers that GlaxoSmithKline (GSK) is withdrawing all lots of its weight loss product Alli from the U.S. market because some packages were tampered with and may contain other kinds of pills. 

Mar 31 Five New Guidance Documents

1. Revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.  FDA’s recommended practice when discussing unapproved new uses for approved drugs marketed in the US. 
Download at:  CLICK TO DOWNLOAD

2. Drug Development to Treat the Symptoms of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.

This guidance will assist sponsors in development of drugs for treatment of VFS/ME. 
Download at:  CLICK TO DOWNLOAD  

3. Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.  This guidance gives the FDA’s requirements pertaining to allowable excess volume in injectable vials. 
Download at:  CLICK TO DOWNLOAD

4. Draft Guidance for Industry on Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations.  This draft guidance revises those parts of the March 2003 guidance entitled “Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations”.   Download Federal Register Notice at:   CLICK TO DOWNLOAD 

5. Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.   The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. 
Download at:  CLICK TO DOWNLOAD

Mar 31  Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical Ingredients.  Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling the following products: African Black Ant (Lot# 2006-000926), Black Ant (Lot# 2006-3627878), XZen Gold (Lot# 130310GL), ZXen Platinum (Lot# 130520PL), XZen 1200 (Lot# 13051012), XZone Gold (Lot# 131110GL), and XZone 1200 (Lot# 13071012) at the retail level due to undeclared sildenafil and tadaiafil.

Mar 27  All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing.   FDA and industry have taken action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. 

Mar 26   Pure Edge Nutrition, LLC Issues Voluntary Nationwide Recall of Bella Vi Brand Products Due to Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses.

Mar 26   New Life Nutritional Center Issues Voluntary Nationwide Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein.  The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. 

Mar 26  Warning Letters – Issued to Mr. Eaga Purushotham, Smruthi Organics Ltd., Solapur, 413 001 India citing the following:

1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards.

2. Failure to maintain and make available for inspectional review production and control records for currently marketed APIs.

3. Inadequate investigations of critical deviations or a failure of a batch to meet its specifications or quality standards.

Mar 25   FDA approves Otezla to treat psoriatic arthritis.  The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).  PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.

Mar 24   Safe Use Initiative: Collaborating to Reduce Preventable Harm from Medications.  You can view the slides from this presentation at:  VIEW PRESENTATION

Mar 21   CDER SBIA Chronicles: GDUFA – Where Are We Now?  The topic of this month’s issue of the FDA/ CDER Small Business Chronicles: GDUFA – Where Are We Now?  You can download your copy at:  CLICK TO DOWNLOAD

Mar 19   Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient.  This product was promoted and sold for weight loss and sold on various websites and in some retail stores.  FDA laboratory analysis confirmed that Vitaccino Coffee contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons.

Mar 17   Recalls – Class III 

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only. Manufactured for: Qualitest Pharmaceuticals, Huntsville,  AL NDC 51079-819-20.  Manufactured by: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Rockford, IL.   Reason:  Failed Impurity/degradation Specification.

Mar 17   Recalls – Class II 

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only, C IV. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50.  Reason: Failed Tablet/Capsule Specifications:   Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Mar 17   SNI National is Voluntarily recalling Kratom XL 4 Pack, Maeng Da Kratom 10 Pack, Max Kratom 20 Pack, and Bali Kratom 40 pack Due to Undeclared Drug Ingredients.  These products contain Kratom (Mitragyna Speciosa).  Kratom is a botanical that qualifies as a dietary ingredient under section 201(f) (1) of the Federal Food, Drug, and Cosmetic Act. When marketed as a dietary ingredient, FDA considers kratom to be a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Furthermore, scientific literature discloses serious concerns regarding the toxicity of Kratom in multiple organ systems. Consumption of Kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms.

Mar 13   CDER Export Certificate Program Frequently Asked Questions. 
Download at:  CLICK TO DOWNLOAD

Mar 13   Pain Free by Nature is Voluntarily Recalling Reumofan Plus Tablets Due to Undeclared Drug Ingredients.  Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased because they contain undeclared active pharmaceutical ingredients: methocarbamol and diclofenac. Use of this product could result in serious and life-threatening injuries (specific injuries were not detailed in the article).

Mar 12   Recalls – Class II

Cyano B-12 (Cmpd) 1000mcg/ml, Dexamethasone (pf) 0.05 % opth., Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic, Dexamethasone phosphate 24mg/ml inj., Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg, Testosterone Cypionate 200mg/ml, Triamcinolone Acetonide 3mg/ml, Vancomycin (fortified) 25mg/ml opth, Vit A (olive oil) 0.1% opth., Vitamin D (Ergocalciferol) 800 u/ml, and Voriconazole 1% opthal.  Manufactured by Natures Pharmacy & Compounding Center, Ashville, NC.  Reason:  Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Mar 12   The FDA Website “Abbreviated New Drug Application (ANDA) Forms and Submission Requirements” has been updated.  View at: CLICK TO VIEW

Mar 12   The FDA Website, “Generic Drugs: Information for Industry” has been updated.  View at:  CLICK TO VIEW  

Mar 7    The FDA Website, “Opioid Patient-Prescriber Agreement” has been updated.  View at: CLICK TO VIEW

Mar 7     Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizer’s Effexor XR® 150 Mg Extended-Release Capsules and One Lot of Greenstone’s Venlafaxine HCl 150 Mg Extended-Release Capsules Due to the Possible Presence of Tikosyn® Capsules.  Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.  This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules

Mar 5     Guidance for Industry:  CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.    You can download a copy at:  CLICK TO VIEW

Feb 28    Guidance for Industry – Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency.  
Download at:  CLICK TO VIEW

Feb 26   Drug Information Update – FDA approves Myalept to treat rare metabolic disease.  On Feb. 24, 2014, the U.S. Food and Drug Administration approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.  Generalized lipodystrophy is a condition associated with a lack of fat tissue. Patients with congenital generalized lipodystrophy are born with little or no fat tissue. Patients with acquired generalized lipodystrophy generally lose fat tissue over time. Because the hormone leptin is made by fat tissue, patients with generalized lipodystrophy have very low leptin levels. Leptin regulates food intake and other hormones, such as insulin. 

Feb 26    FDA’s GDUFA Regulatory Science Initiatives Public Meeting.    FDA is hosting “The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15” Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan.   The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing .  If you wish to attend, either in person or via webcast, or present at the hearing, please email  by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number). Those without email ? access can register by contacting Thushi Amini () by April 25, 2014. If you need special accommodations because of a disability, please contact Thushi Amini at least seven days before the hearing.

Feb 24    Guidance for Industry – New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.   Download this draft guidance at:  CLICK TO DOWNLOAD

Feb 24    Guidance for Industry – Analytical Procedures and Methods Validation for Drugs and Biologics.  Download this draft guidance at:  CLICK TO DOWNLOAD

Feb 18   CDERWorld is a series of educational modules based on The CDER Forum for International Regulatory Authorities Lectures.  The modules present an overview of the work of the Center for Drug Evaluation and Research. After a hiatus, CDERWorld is alive again on our website.  CDER World is an ever-growing compendium of information about how CDER carries out its mission, adapts to new legislative initiatives, and initiates directions in regulatory science to improve the public health. Please take some time to check out this excellent resource!  View at:  http://www.accessdata.fda.gov/scripts/cderworld/?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 19    The slides from the meeting presentation, “FDA Regulation of Controlled Substances: A Review of 2013, What to Expect in 2014” are available at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM388753.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 18    Drug Information Update-FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline.  FDA has tested samples from recalled lots of Medisca’s L-citrulline product, and has found that the samples contain N-acetyl-leucine, which is used to treat a certain type of dizziness (acute vestibular vertigo). No L-citrulline was found in the samples FDA tested.  These results reinforce the FDA’s concern about Medisca’s product labeled as L-citrulline and serve to remind patients and clinics not to use any recalled Medisca L-citrulline product with lot numbers 95482/A, 95482/B, 95482/C, 95482/D and 96453/A, 96453/B, 96453/C, 96453/D. 

Feb 17    MyNicKnaxs, LLC, located in Florida is announcing a recall of: Magic Slim, Fruta Bio, SlimEasy, Super Fat Burning Bomb, Slim Xtreme, Meizi Evolution, Meizitang Strong Version Botanical Slimming, Jianfeijindan Activity Girl, and Japan Hokkaido Cangye Phamacy Co., LTD Japanese Chinese Formula pill for weight reduction.  These products contain undeclared active pharmaceutical ingredients: Phenolphthalein, sibutramine or a combination of both. At this time no illnesses or injuries have been reported to MyKnicKnaxs, LLC, in connection with these products. 

Feb 17    Ben Venue Laboratories, Inc. Issues A Voluntary Nationwide Patient Level Recall Of Acetylcysteine Solution 10%, USP,  Lot 2005479.   This voluntary recall was initiated after the discovery of a single visible glass particle in a vial within the lot listed above. There have been no complaints or adverse events related to a piece of glass in vials of this lot.

Feb 14    Public Notification - Arth-Q Contains Hidden Drug Ingredient.  The Food & Drug Administration (FDA) is advising consumers not to purchase or use Arth-Q, a product promoted & sold as a dietary supplement for joint, muscle & arthritic pain.  FDA laboratory analysis confirmed that Arth-Q contains the active ingredient, ibuprofen.

Feb 13    Introducing CDER SBIA.   Formerly known as the CDER Small Business Program, we will now be known as CDER Small Business and Industry Assistance (CDER SBIA).  CDER SBIA’s mission is to promote productive interaction with regulated domestic and international small pharmaceutical business and industry by providing timely and accurate information relating to the development and regulation of human drug products.  

Feb  11   Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Receipt Date.               
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry – Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food, Drug, and Cosmetic Act. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Standardized Study Data. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Draft Guidance for Industry on Analgesic Indications:  Developing Drug and Biological Products.                This guidance provides recommendations to sponsors on the development of prescription drugs for the management of acute and chronic pain, as well as the management of breakthrough pain. Specifically, this guidance focuses on drug development and trial design issues and chemistry, manufacturing, and controls concerns that are unique to the study of acute, chronic, and breakthrough pain and the labeling considerations for analgesic drugs. 
Download at:  CLICK TO DOWNLOAD

Feb 11    Guidance for Industry and FDA Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information. 
You can download at:   CLICK TO DOWNLOAD

Feb 11    GDUFA Regulatory Science Initiatives Public Meeting and Webcast on May 16, 2014, in Silver Spring, MD.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing .  If you wish to attend, either in person or via webcast, or present at the hearing, please email by April 25, 2014. The email should contain complete contact information for each attendee (i.e., name, title, affiliation, address, email address, and telephone number).  

Feb 7      Guidance for Industry and Food and Drug Administration Staff - Annual Reports for Approved Premarket Approval Applications (PMA).  You can download a pdf version at:  CLICK TO DOWNLOAD 

Feb 6      FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  At this time, FDA has not concluded that FDA approved testosterone treatment increases the risk of stroke, heart attack, or death.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.  Example conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Other examples include problems with the hypothalamus and pituitary that control the testicles’ production of testosterone.  None of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.

 Feb 5      FDA has presented the fiscal year (FY) 2013 Generic Drug User Fee Amendments of 2012 (GDUFA) Performance Report to the President and Congress. This performance report covers the period of October 1, 2012, through September 30, 2013, and presents FDA’s accomplishments for the first year of GDUFA and expectations for the future.  You can read it at:  CLICK TO READ

Feb 4      The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.  Non-24 occurs in persons who are completely blind. Light does not enter their eyes and they cannot synchronize their body clock to the 24-hour light-dark cycle.  Those with the disorder may have difficulty falling asleep or staying asleep, and may wake up groggy or feeling as if they need more rest. People with non-24 may find their sleep patterns reversed -- needing to sleep during the day and to be awake at night.

Feb 3      FDA is evaluating risk of stroke, heart attack and death with FDA-approved testosterone products.  Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone because of reasons such as genetic problems or chemotherapy.  Read more at:  CLICK TO READ

Jan 31    Guidance for Industry - Guidance Agenda: New & Revised Draft Guidance CDER is Planning to Publish During Calendar Year 2014.  Download your copy at: 

CLICK TO DOWNLOAD

Jan 29    Recalls – Drugs Class II

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.   Reason:   Presence of Foreign Substance: The products are being recalled because they may contain foreign substances 

Jan 24    Improving the Quality of ANDA Submissions.  FDA is establishing a public docket to receive  input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements. Specifically, FDA is interested in hearing about difficulties sponsors are having developing and preparing their ANDA submissions.  FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry.  Improving the quality of ANDA submissions will result in more submissions accepted for filing, fewer amendments and easily correctable deficiencies (ECDs), and ultimately, more generic drug approvals.  FDA welcomes comments at any time, but we encourage submission of electronic or written comments to http://www.regulations.gov or Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 by March 24, 2014.

Jan 22    FDA/CDER Small Business Chronicles – Improving Drug Supply Chain Integrity.   The purpose of the newsletter, the FDA/CDER Small Business Chronicles, is to provide industry with useful information to assist in all aspects of drug marketing and regulation. This newsletter is issued every other month.  Download and print your copy today:   CLICK TO DOWNLOAD

Jan 22    Recalls – Drugs Class II

Numerous incidents of gross drug product mislabeling by AidaPak Service – one example:  PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304  Reason:  Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.

Jan 17    FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers.   There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.

Jan 15    FDA is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce.  Read more in the Federal Register Notice at:  CLICK TO READ 

Jan 14    FDA announces the Availability of a draft guidance on “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics”.  This guidance is posted at:  CLICK TO VIEW 

Specialty Pharma Newsletter - November-December 2013 

Jan 8      Recalls Class III

Cetirizine Hydrochloride Syrup, 1 mg/mL, Rx Only NDC 0603-9063-54 (120 mL bottle) and NDC 0603-9063-58 (480 mL bottle).  Distributed by Qualitest Pharmaceuticals, Huntsville, AL 35811.  Reason: Failed impurities/degradation specification – out of specification for known impurity 4-chlorobenzophenone.

G&W Fluocinolone Acetonide Cream USP 0.025% a) 15 gram (NDC 0713-0222-15) and b) 60 gram (NDC 0713-0222-60), Rx Only.  Manufactured by G&W Laboratories, Inc. South Plainfield, NJ 07080.  Reason: Failed Content Uniformity Specification at the 18 month time point.            

Jan 8      FDA approves Farxiga to treat type 2 diabetes.  The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.  Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. The drug’s safety and effectiveness were evaluated in 16 clinical trials involving more than 9,400 patients with type 2 diabetes. The trials showed improvement in HbA1c (hemoglogin A1c or glycosylated hemoglobin, a measure of blood sugar control).   An increased number of bladder cancers were diagnosed among Farxiga users in clinical trials so Farxiga is not recommended for patients with active bladder cancer. Patients with a history of bladder cancer should talk to their physician before using Farxiga. Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function.

Jan 8      Guidance for Industry

Draft Guidance on Naming of Drug Products Containing Salt Drug Substances.   Under the new policy, drug names and strengths for new compendial drug products will be based on the active moiety. The name and strength of the active ingredient (e.g., salt) will appear elsewhere on the drug product label and labeling.  You can download the draft guidance at:  CLICK TO DOWNLOAD

Guidance on Qualification Process for Drug Development Tools.  This guidance describes the qualification process for drug development tools intended for potential use, over time, in multiple drug development programs. The guidance provides a framework for interactions between FDA and sponsors to support work towards qualification of an identified drug development tool and creates a mechanism for formal review of data to qualify the tool and ensure that the evaluation is comprehensive and reliable.  A copy can be downloaded at:   CLICK TO DOWNLOAD

Draft Prescription Drug User Fee Act V Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Download a copy at:  CLICK TO DOWNLOAD   

Draft Generic Drug User Fee Act Information Technology Plan.  This plan is intended to provide FDA's approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the Generic Drug User Fee Act (GDUFA) Performance Goals and Procedures for Fiscal Years 2013 through 2017. FDA is publishing a draft version of the IT plan for comment to allow industry and other interested stakeholders to provide feedback as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals.  Get your copy at:  CLICK FOR COPY

Jan 1      Recalls – Class II

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, NDC 0781-2102-01, Rx Only.  Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, N.J.  Reason:  Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin.

Carisoprodol IV (Carisoprodol Tablets USP) 350mg, RX only. Manufactured by Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked & Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 ct bottle: NDC: 54868-0816-8, 60 ct bottle: NDC: 54868-0816-4, 30 ct bottle: NDC: 54686-0816-3.  Reason:  Presence of Foreign Substance; heavy metals (chromium, titanium, etc.) and inactive components of the product were visually observed during routine stability testing. 

specialty pharma newsletter january 2013 prepared feb 11 2013 final.doc

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