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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Apr 16   FDA Webinar:  Draft Guidance for Industry - Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.   On Wednesday, AOn Wednesday, April 23, 2014, from 1:00 p.m. – 2:00 p.m. EDT, FDA will present a webinar on the draft guidance for industry Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment.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 linkhttps://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 emailJeffery.Rexrode@fda.hhs.gov 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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 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 2nd 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 and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and 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 and 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 August 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 sibutramineSibutramine 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:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm391102.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Apr 9     Guidance for Industry:  Immunogenicity-Related Considerations for Approval of Low Molecular Weight Heparin for NDAs and ANDAs.   You can download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM392194.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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 and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and 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 United States. 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: DrugTrackandTrace@fda.hhs.gov        

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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387652.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

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:  http://www.fda.gov/drugs/newsevents/ucm319188.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery   

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:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389069.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:   https://www.federalregister.gov/articles/2014/03/18/2014-05849/draft-guidance-for-industry-on-bioavailability-and-bioequivalence-studies-submitted-in-new-drug?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov  

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:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm390058.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 31  Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical IngredientsNova 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:  http://www.fda.gov/downloads/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/UCM389827.pdf

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:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM390003.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ImportsandExportsCompliance/UCM388842.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm120955.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Mar 12   The FDA Website, “Generic Drugs: Information for Industry” has been updated.  View at:  http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ucm142112.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery   

Mar 7    The FDA Website, “Opioid Patient-Prescriber Agreement” has been updated.  View at: http://www.fda.gov/Drugs/DrugSafety/SafeUseInitiative/ucm377231.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 28    Guidance for Industry – Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM387446.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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 GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please email GDUFARegulatoryScience@fda.hhs.gov 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 (Thushi.Amini@fda.hhs.gov) 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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM386685.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 24    Guidance for Industry – Analytical Procedures and Methods Validation for Drugs and Biologics.  Download this draft guidance at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386366.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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 and Drug Administration (FDA) is advising consumers not to purchase or use Arth-Q, a product promoted and sold as a dietary supplement for joint, muscle and 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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072385.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384686.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Standardized Study Data.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm384691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Feb 11    Guidance for Industry and FDA Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information.  You can download at:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm233769.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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 GDUFARegulatoryScience@fda.hhs.gov.  If you wish to attend, either in person or via webcast, or present at the hearing, please emailGDUFARegulatoryScience@fda.hhs.gov 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:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089398.pdf  

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:  http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM384177.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/Drugs/DrugSafety/ucm383904.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf

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:   http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM382403.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  https://www.federalregister.gov/articles/2014/01/10/2014-00257/unapproved-and-misbranded-oral-and-injectable-drugs-labeled-for-prescription-use-containing-codeine?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

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:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM381352.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm379753.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               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:   http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm230597.pdf

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:  http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM379847.pdf   

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:  http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM379851.pdf

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 and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count 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.

 Dec 26    Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan.  On December 26, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan.  The plan explains FDA’s approach for enhancing business processes, data quality and consistency, supporting technologies, and IT operations as described in the GDUFA Performance Goals and Procedures for Fiscal Years 2013 through 2017.  FDA is requesting comments from industry and other interested stakeholders as FDA moves towards a fully automated standards-based environment that enhances the regulatory review process for human pharmaceuticals. You can review the 5 year plan at:  http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM379851.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Dec 23   Deseo Rebajar, Inc., Issues Voluntary recall of Burn 7 Capsules Due to Undeclared Active Ingredient.  The FDA laboratory analysis of this dietary supplement found the Burn 7 Capsules product to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias,, or stroke.     

 Dec 23    The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.  The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances.   Mass Destruction is manufactured for Blunt Force Nutrition in Sims, NC and sold in retail stores, fitness gyms, and on the Internet.

 Dec 21    FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy.  The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.  Contaminated sterile drugs put patients at risk of serious infection. Health care professionals who have received the affected products should stop using them.  The FDA is aware of one adverse event associated with mineral IV injection produced by Abrams’ lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection. 

 Dec 20    Warning Letters

Issued to Jonnie R. Williams, CEO, Star Scientific, Inc., 4470 Cox Road, Suite 110, Glen Allen, VA 23060.   Reason:  Your website promotes Anatabloc for conditions that cause the product to be a drug.  In addition your Anatabloc and CigRx products contain anatabine as a dietary ingredient.  While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval.  To date, a premarket notification has not been submitted to the FDA, for your products containing anatabine; therefore, your products are deemed to be adultrated.        

 Dec 19    Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph.  FDA issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.   This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.  You can read more at:  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm378122.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Dec 18    Recalls – Class III

Oxcarbazepine Tablets, 150 mg, packaged in  a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100 count bottle (NDC 0054-0097-25), Rx Only.  Manufactured by Roxane Laboratories, Inc., Columbus, Ohio 43216.  Reason: Sub-Potent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

                Bumetanide Tablets USP 0.5 mg  a) 100-count Bottle, NDC 0185-0128-01 b) 500-count Bottle, NDC 0185-0128-05, Rx Only.  Manufactured by Sandoz Inc., Princeton, NJ 08540.  Reason:  Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

 Dec 18   Recalls – Class II

Phenytoin Oral Suspension USP, NDC 66689-036-5012, 5mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only. Manufactured by: Vista Pharm, Inc., Largo, FL 33771.  Reason:  Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability time point.

 Dec 18    FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers (“Changes Being Effected” Supplements proposed rule).   FDA has decided to extend the comment period by 60 days for the proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (“Changes Being Effected” Supplements proposed rule). The comment period on the proposed rule will be extended to March 13, 2014, and the comment period on information collection issues under the Paperwork Reduction Act of 1995 will be extended to February 11, 2014. 

 Dec 18    The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.  Taking part in this initiative are the EMA and the EU member states France, Germany, Italy, the Netherlands and the United Kingdom.

Dec 17    FDA Drug Safety Communication: FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes.  The U.S. Food and Drug Administration (FDA) is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.  Priapism can occur in males of any age and happens when blood in the penis becomes trapped, leading to an abnormally long-lasting and sometimes painful erection. Younger males, especially those who have not yet reached puberty, may not recognize the problem or may be embarrassed to tell anyone if it occurs.  All male patients and their caregivers should be taught the signs and symptoms of priapism and the importance of seeking immediate medical treatment if it occurs.

 Dec 12    The U.S. Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.  Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market duloxetine in various strengths.

Dec 9      Guidance for Industry:  Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.  You can download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377938.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 4      Recalls – Class I

J.R. Jack Rabbit All Natural Herbal Supplement, One tablet can last 24-72 hours, 4-count tablets per blister pack.   Marketed by Jack Rabbit Inc., 4355 Dow Road, Melbourne, FL 32934.  Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.

 Dec 4      Recalls – Class II

Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, NDC 0228-4025-11, Rx Only.   Manufactured by Actavis Elizabeth, LLC, Elizabeth, NJ,.  Reason: Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below specification in some tablets.        

               Acyclovir Tablets USP 800 mg, (NDC 60505-5307-1), Rx only.  Manufactured by Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for Apotex Corp., Weston, Florida 33326.  Reason:  Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitrile rubber glove embedded within the tablets.

Dec 4      Guidance for Industry – Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Dec 2      Guidance for Industry.

Interim Product Reporting for Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.   You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377050.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.   You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377051.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Pharmacy Compounding of Human Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act.  You can download this draft Guidance at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (Draft)

When finalized, this draft guidance will replace the guidance of the same title issued January 25, 2012. The draft guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs and articulates the circumstances under which FDA intends to exercise enforcement discretion.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070076.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Dec 2      Federal Register Notices

Over-the-Counter Ophthalmic Drug Products – Emergency Eyewash Products; Rescheduling of Public Hearing.  FDA is rescheduling a December 4, 2013, public hearing to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency use eyewash products, announced in the Federal Register of Wednesday, September 18, 2013. Based on a request received by the Agency, we are rescheduling the public hearing to March 7, 2014, and updating the related procedural dates that appeared in the September 18, 2013, notice.  Read the Federal Register Notice at:  https://www.federalregister.gov/articles/2013/11/15/2013-27359/over-the-counter-ophthalmic-drug-products-emergency-use-eyewash-products-rescheduling-of-public?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

   Nov 29   IQ Formulations Issues a Voluntary Recall of HYDRAVAX Dietary Supplement Due to Possible Undeclared Ingredient.  IQ Formulations, of Sunrise, Florida is initiating a precautionary and proactive recall of all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of HYDRAVAX (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic.

Nov 27               Recalls – Class II                                                                              

Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, NDC 0025-1031-31, Rx only.  Manufactured by G.D. Searle, Division of Pfizer, Inc., NY, NY 10017.   Reason:  Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 Capsules per bottle, NDC: 62175-118-43, Rx Only.  Manufacturer: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA.  Reason:  Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.

 Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, NDC 0054-0199-59, Rx only. Manufacturer: Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216.   Reason: Re-suspension Problems: Recalled lot did not meet resuspendability requirements.

 Nov 22   FDA expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.  Thyroid cancer is a cancerous growth of the thyroid gland, which is located in the neck. Differentiated thyroid cancer is the most common type of thyroid cancer. The National Cancer Institute estimates that 60,220 Americans will be diagnosed with thyroid cancer and 1,850 will die from the disease in 2013.  Nexavar works by inhibiting multiple proteins in cancer cells, limiting cancer cell growth and division. The drug’s new use is intended for patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that no longer responds to radioactive iodine treatment.  Thyroid stimulating hormone, a potential promoter of thyroid cancer, is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone replacement therapy.

Nov 14   FDA/CDER Small Business Chronicles – Communicating with CDER.   The topic of this month’s issue of the FDA/CDER Small Business Chronicles is Communicating with CDER.   To facilitate the conduct of efficient and effective drug development programs, it is very important for potential drug sponsors to engage with CDER early in the drug development process. This newsletter discusses different avenues of communication that are available for small business to communicate with CDER.    Download your copy at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM374882.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Nov 13   Recalls – Class II

               Ciprofloxacin Tablets, USP, 500 mg, 250 mg,  100-count bottles, NDC 0378-7098-01 and NDC 0378-7097-01,  Rx only.  Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.   Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

                Amlodipine Besylate and Benazepril HCl Capsules, All Strengths, 100-count bottles, NDC 0378-6900-01 and others, Rx only.   Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.   Reason:  CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.          

                Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only.  Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.  Reason:  CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Nov 12   Guidance for Industry

ANDA Submissions – Refuse to Receive Standards.  Published in October 2013, you can download a copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm370352?source=govdelivery&utm_medium=email&utm_source=govdelivery                   

Nov 8     FDA Approves First Generic Versions of Aciphex Delayed-Release Tablets to Treat GERD.  The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).   GERD, also called acid reflux or acid regurgitation, is a common condition in which backward flow of acid from the stomach causes heartburn and possible injury to the esophagus (the tube that connects the throat and stomach).   Dr. Reddy’s Laboratories Ltd., Kremers Urban Pharmaceuticals Inc., Lupin Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic rabeprazole.

 Nov 6     FDA takes two important actions on drug shortages.  FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients.   First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing.  Second, the FDA issued a proposed rule requiring all manufacturers of certain medically important prescription drugs to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt their supply. The rule also extends this requirement to manufacturers of medically important biologic products. The proposed rule implements the expanded early notification requirements included in FDASIA.  To read the proposed rule, go to:  https://www.federalregister.gov/articles/2013/11/04/2013-25956/permanent-discontinuance-or-interruption-in-manufacturing-of-certain-drug-or-biological-products?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Nov 6    Guidance for Industry

               Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.   Download a copy at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm071185.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Nov 4     Perrigo Initiates Nationwide Voluntary Product Recall of 18 Batches of Acetaminophen Infant Suspension Liquid, 160 mg/5 mL, Due to a Potential Defect with the Co-packaged Oral Syringe.  The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings.

Nov 4     Guidance for Industry

               ANDAs: Stability Testing of Drug Substances and Products.  Download a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072873.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                              A companion guidance is also available: Questions and Answers.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Nov 4     Drug Information Update - Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal.  The U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.

Nov 1     Drug Information Update - Proposed Hydrocodone Reclassification.  In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products.  Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule.  By early December, FDA plans to submit this formal recommendation package to HHS.

          

                 Specialty Pharma Newsletter (Sept-Oct 2013) 

Oct 18    OPDP Enforcement Actions Webinar –  January 30, 2014 at 11:00 AM.   The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on January 30, 2014, from 11:00 AM to 12:00 PM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through September 2013. To join the meeting: https://collaboration.fda.gov/opdp1028

 Oct 18    Warning Letters

               Issued to Nephron Pharmaceuticals Corporation, 4121 SW 34th Street, Orlando, FL 32811.  Reason:

               The over-the-counter (OTC) drug product Asthmanefrin (NDC 0487-2784), a bronchodilator contains the active ingredient racepinephrine hydrochloride.  Based on the active ingredient and the claims made for this product, Asthmanefrin is a "new drug" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its labeled uses. 

               Issued to Dolgencorp, Inc., 100 Mission Ridge, Goodiettsville, Tennessee 37072, 

Homeolab USA 3025 boul de l’Assomption Blvd., Montreal, QC H1N 2H2 Canada,

Insight Pharmaceuticals, LLC, 900 Northbrook Drive, Suite 200, Trevose, PA 19053,

Medtech Products, Inc., 90 N. Broadway, Irvington, NY 10533, and

Topco Associates, LLC, 7711 Gross Point Road, Skokie, IL 60077

 Reason:  “Rexall Earache Relief Drops”, “Kids Relief Earache”, and “Auro Earache Relief Ear Drops”  “Murine Eardrops for Earache Relief” and “TopCare Earache Relief Ear Drops” are prescription drugs within the meaning of Section 503(b)(1) of the Act because it is intended to treat diseases that requires diagnosis and treatment by a physician or is intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Ear pain (earache) is not a currently recognized OTC indication in the final monograph for topical otic drug products (21 CFR 344) or in any approved OTC new drug application.

 Issued to Brower Enterprises, 1002 E. Fifth Street, Canton, South Dakota 57013.  Reason: During an inspection of your facility our investigators found significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations, found in 21 CFR 111. These violations cause your products Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.

                Issued to Pure Energy Products, Inc., 6409 S Western Avenue, Oklahoma City, OK 73139.  Reason:  During the inspection, our investigator noted that you distribute obestrim, which declares 1,3-dimethylamylamine as a dietary ingredient. This ingredient is also called, among other names, dimethylamylamine, DMAA or methylhexanamine, and will be referred to in the rest of this letter as “dimethylamylamine”.  As explained below, dimethylamylamine is not a dietary ingredient. Rather, it is an unsafe food additive that causes your dimethylamylamine-containing product to be adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(2)(C)(i)] because it is a food to which dimethylamylamine, a drug approved under section 505 of the Act [21 U.S.C. § 355], has been added. 

               Issued to Y.S. Health Corp, 411 Kingston Court, Mt. Prospect, IL 60056.  During a recent inspection serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111) were found. These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 342(g)(1)], in that the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.  Unapproved new drug violations were also found (Arth 2000+ Cream).

 Issued to GumRunners, LLC, 333 Washington Street, FL-2, Jersey City, NJ 07302.  Reason: Your products Spearmint Jolt Energy Gum, Icy Mint Jolt Energy Gum, and Mint Flurry Energy Mints, offered on your website are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].   Claims found are:  “Prevents Parkinson’s disease”, “Prevents skin cancer”, “Prevents dry-eye syndrome”,  “Helps control ADHD”, “Can help breathing in young babies”, and “Curbs Depression”.

 Oct 16    Guidance for Industry All can be downloaded at: Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

1)      Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071185.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

2)      Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions, Annex 14, Bacterial Endotoxins Test General Chapter.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM219167.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

3)      Q3D Elemental Impurities.   Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM371025.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 Oct 10    Resolved Drug Shortages – Tamiflu (oseltamivir) Oral Suspension 6 mg/mL produced by Genentech.

 Oct 10    Public Notification: The following products contain a hidden drug ingredient: sibutramine:

               “Bella Vi Insane Amp’d”, “Bella Vi Amp’d Up”, “Be Inspired”, “Dr. Mao Slimming Capsules”, “Perfect Body Solutions”, and “Burn 7”.  These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Oct 8      Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act were sent to Genzyme, Amedra Pharmaceuticals, The Medicines Company, Salix Pharmaceuticals, Sunovion Pharmaceuticals, Pfizer, and Nautilus Neurosciences.  Section 505B(d)(1) of the “Act” requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension, or have failed to request approval for a required pediatric formulation. 

Oct 3      FDA approves Duavee to treat hot flashes and prevent osteoporosis.  The U.S. Food and Drug Administration today approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and to prevent osteoporosis after menopause.

Oct 3      Guidance for Industry

               Comprehensive List of Guidance Documents (updated).  Download at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079645.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               New/Revised/Withdrawn CDER Guidance:  Download at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM254636.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Oct 2      FDA warns of increased risk of death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning.  FDA has issued a Drug Safety Communication (or DSC) warning that an additional analysis shows an increased risk of death when intravenous (or IV) Tygacil (or tigecycline) is used for FDA-approved uses as well as for non-approved uses.  Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable.

 Oct 2      Guidance for Industry – Refuse to Receive Standards.  This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission.   Download at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM370352.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               Draft Guidance for Industry on Bioanalytical Method Validation.  This draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics.  Download at:

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format.   This draft guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.  Download at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format.  This draft guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Guidance for Industry on Electronic Source Data in Clinical Investigations.  This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.  Download at:  http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm328691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation.  This draft guidance document provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for INDs, NDAs, and BLAs. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.  Download at:  

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm369043.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Oct 1      The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.   Major depressive disorder (MDD), commonly referred to as depression, is a mental 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. Episodes of depression often recur throughout a person's lifetime, although some may experience a single occurrence.

Sep 30    FDA approves Perjeta for neoadjuvant breast cancer treatment.  The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.  Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease.

               Recalls – Class II

               IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.  Labeling: Incorrect or missing lot and/or expiry date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.

Sep 24    Public Workshop - Complex Issues in Developing Drug and Biological Products for Rare Diseases.  The purpose of the workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases, including endpoint development and selection, use of surrogate endpoints and the accelerated approval pathway, clinical trial design, conduct and analysis, safety considerations, and dose selections; and to discuss ways to encourage and accelerate the development of new therapies for pediatric rare diseases. FDA is seeking input on these topics from academic, clinical, and treating communities; patients and advocacy groups; industry; and government agencies.

Date:                        January 6-7, 2014

Time:           8:00 a.m. to 5:00 p.m.

Location:     FDA White Oak Campus
                    10903 New Hampshire Avenue,
                    Bldg. 31, Room 1503 (Great Room)
                    Silver Spring, Maryland 20993

               To read the agenda go to:  http://www.fda.gov/downloads/Drugs/NewsEvents/UCM370418.pdf

 Sep 24       FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.  Fentanyl patches are dangerous even after they’ve been used because they still contain high amounts of strong narcotic pain medicine.  Used fentanyl patches require proper disposal after use―fold the patch, sticky sides together, and flush it down the toilet right away.

Sep 20    FDA/CDER Small Business Chronicles.  This month’s issue is entitled “Safety Labeling Changes for Prescription Drugs”.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM369229.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery                                              You can find more information in the guidance located at:     http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM250783.pdf        

Sep 18    Federal judge approves consent decree against Shamrock Medical Solutions Group.   A Federal Judge has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.  Shamrock Medical repackages and distributes solid and liquid oral non-sterile drug products for human use to hospitals throughout the country. Recent FDA inspections found several violations at the facility, including failure by the quality control unit to fully follow its own quality control procedures and to examine packaged and labeled products to ensure correct labeling. The FDA has previously sent warning letters to Shamrock Medical for violating current good manufacturing practices (CGMP) and distributing incorrectly labeled drugs.  

Sep 18   Guidance for Industry

               Patient Counseling Information Section of Labeling for Human Drug and Biological Products – Content and Format.   To download a copy go to: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM368602.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               Electronic Source Data in Clinical Investigations.    Download at: http://www.fda.gov/downloads/Dru, g, s/GuidanceComplianceRegulatoryInformation/Guidances/UCM328691.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery 

Sep 16    FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert.  The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).  Under the decree, Ranbaxy is prohibited from manufacturing FDA-regulated drugs at the Mohali facility and introducing drugs into interstate commerce, including into the United States, from the Mohali facility until the firm’s methods, facilities, and controls used to manufacture drugs at the Mohali facility are established, operated, and administered in compliance with CGMP. 

Sep 16    Video Game Training Improves Cognitive Control in Older Adults.  Researchers found that seniors who play a 3-D video game improve their ability to sustain focus and multitask successfully. The results highlight the potential of the aging brain to improve certain skills.  During multitask training, participants used a joystick to maintain a moving car in the center of a winding road while also responding to road signs that popped up. As participants improved, the games got harder.  Seniors who played the multitasking game on a laptop at home for 1 hour a day, 3 times a week for 4 weeks (12 hours of total training) significantly improved their multitasking performance index at the end of the training period.

Sep 12    FDA approves Botox Cosmetic to improve the appearance of crow’s feet lines.  OnabotulinumtoxinA is the only FDA approved drug treatment option for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults.

Sep 11    Guidance for Industry

               Generic User Fee Amendments of 2012: Questions and Answers.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM316671.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               Guidance for Clinical Investigators, Sponsors, and IRBs – INDs Determining Whether Human Research Studies Can Be Conducted Without an IND.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

 

Sep 10    Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots 
Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor.
   The following products and lot numbers are subject to the nationwide recall:

·               Bevacizumab Lot No. 08052013@1, expiry 11/03/13

·               Bevacizumab Lot No. 08052013@4, expiry 11/03/13

·               Lidocaine/phenylephrine Lot No. 07302013@6, expiry 10/28/13

The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

Sep 10    FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics.  The updated indication further clarifies that, because of the risks of addiction, abuse, and misuse, even at recommended doses, and because of the greater risks of overdose and death, these drugs should be reserved for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain; ER/LA opioid analgesics are not indicated for as-needed pain relief.

Sep 10    Fee for Using a Priority Review Voucher in Fiscal Year 2014.  FDA is announcing the fee for using a tropical disease priority review voucher for fiscal year (FY) 2014 of $2,325,000.  Read more in the Federal Register here:  https://www.federalregister.gov/articles/2013/09/05/2013-21542/fee-for-using-a-priority-review-voucher-in-fiscal-year-2014?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

Sep 10    Autism Spectrum Disorder now affects about 1 in 88 children.  Read more at:  http://newsinhealth.nih.gov/issue/Sep2013/Feature1

Sep 6      McNeil Consumer Healthcare Announces Voluntary Recall of Three Lots of Concentrated MOTRIN Infants Drops Original Berry Flavor 1/2 fluid ounce.  After releasing these three lots of Concentrated MOTRIN® Infants’ Drops Original Berry Flavor 1/2 fluid ounce into the market, tiny plastic particles (approximately 1 mm in size or about the size of a poppy seed) were identified in a different product lot produced using the same batch of active ingredient, ibuprofen, during manufacturing.  The recalled lots are DCB3T01, DDB4R01, and DDB4S01.

Sep 5      Guidance for Industry

               Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration (Draft).   This guidance can be downloaded from:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM367199.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

               ANDAs: Stability Testing of Drug Substances and Products Q&A.  Copies available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Aug 23   Announcements

               Secure Supply Chain Pilot Program (SSCPP).  The SSCPP is intended to assist the FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the Agency to focus its resources on imported drugs that fall outside the program and may pose risks.  The FDA will be accepting applications for participation in the SSCPP beginning September 16, 2013 and until December 31, 2013.  To read the Federal Register announcement go to:  http://www.gpo.gov/fdsys/pkg/FR-2013-08-20/pdf/2013-20215.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

                Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidance.

               This initiative at CDER will involve the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidance should be withdrawn, revised, or finalized with only minor changes.  There is more to read in the Federal Register notice located at:   http://www.gpo.gov/fdsys/pkg/FR-2013-08-07/pdf/2013-19051.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery    

Aug 21   Recalls – Class III

               Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20.  Reason: Labeling: Missing Label; missing label on blister card.

                buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01.

               Reason:  Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.

Aug 21   Recalls – Class II

               Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b) Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61, c)Wal-Zan brand 150, MAXIMUM STRENGTH, 24 count bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 63015, NDC 0363-0404-34.  Reason:  Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.

               Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887

               Reason:  Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.

Aug 16   Herbal Give Care LLC Issues Voluntary Nationwide Recall of Esbelder Man Capsules, Esbelder Fem Capsules, and Esbelder Siloutte Capsules Vitamin Supplements Due to Potential Health Risks.

               Grand Prairie, Texas, Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder silhouette (30 capsules) to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine.  These products may 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.

                  Specialty Pharma Newsletter (July-Aug 2013) 

Aug 18   Aidapak Services LLC Initiates Voluntary Recall of Selected Pharmaceuticals Repackaged by Aidapak Services LLC Due to Potential Incorrect Labeling.  Aidapak Services LLC is conducting a voluntary recall of specific unit dose repackaged products sent to 25 hospital inpatient pharmacies in the States of Washington, Oregon, California, and Arizona for products listed on the company’s website. The Firm voluntarily recalled these products to the hospital/user level after learning of possible incorrect labeling which could involve OTC, prescription, and dietary supplement products.  All products affected by this recall are stamped with AidaPak’s packaging stamp. Products not stamped with AidaPak’s packaging stamp are not affected by this recall.

                                             

Aug 15   FDA Requires Label Changes to Warn of Risk for Possibly Permanent Nerve Damage From Antibacterial Fluoroquinolone Drugs Taken by Mouth or by Injection.  The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.  Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive).  The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.  Symptoms include pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or the sense of body position.  It can occur at any time during treatment with fluoroquinolones and can last for months to years after the drug is stopped or be permanent.  Patients using fluoroquinolones who develop any symptoms of peripheral neuropathy should tell their health care professionals right away.

Aug 15   Specialty Compounding, LLC is voluntarily recalling all lots of sterile medications within expiry. Note: An earlier version of this news release indicated that the recall applied to all unexpired sterile compounded products dispensed since May 9, 2013; however, the recall applies to any sterile medication that has not reached its expiration date, including all strengths and dosage forms.  The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding.  There is a potential association between the infections and the medication at this time.  No calcium gluconate was shipped outside of the State of Texas.

Aug 15   FDA Small Business REdI Conference Fall 2013 – Registration now OPEN.  The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH). The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations.   It will be held September 25-26 at the Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD.   This event is FREE!   Register at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm364584.htm?source=govdelivery

Aug 14   Recalls – Class I   

               Reumofan Plus, 30-count tablets per bottle.  Distributed by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.

               Reason for Recall:  Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.  Distributed nationwide through Internet sales

               Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle.  Manufactured by: Cadila healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10

               Reason for Recall:  Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

Aug 14   Recalls – Class II

               Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages.  Distributed by Novartis Consumer health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.

               Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches.   Distributed by Novartis Consumer health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging does not have NDC numbers.

               No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch.   Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02

               Reason for Recalls:  Defective container: products are packaged in pouches which may not have been fully sealed.              

               Recalls – Class III

               Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only,   Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36.

               Reason for Recall:  Contraceptive tablets out of sequence in Lots: LF01643C, LF01644C, Exp 7/14

                BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only.  Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6.

               Reason for Recall:  Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.

Aug 14   Warning Letters

               Issued to James G. Dina, Owner, Natural Products Services, Inc., 620 S. Andreasen Drive, Escondido, CA, 92029.   Reasons: 1. Unapproved New Drugs, and 2. Adulterated Dietary Supplements (lack of identity testing and failure to establish product specifications).

               Issued to Robert Occhifinto, President/Owner, N.V.E. Pharmaceuticals, Inc., 15 Whitehall Road, Andover, New Jersey 07821.  Reasons:  1. Failed to establish required specifications for stages in their manufacturing processes where control is necessary to ensure the quality of the dietary supplements produced, 2. Failed to establish component specifications and product specifications, 3. Failure to test products and components for conformity to specifications.

 Aug 9     OPDP Enforcement Actions Webinar – October 28, 2013 at 10:30 AM.   The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on October 28, 2013, from 10:30 AM to 11:00 AM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through September 2013.   To join the meeting as a guest:   https://collaboration.fda.gov/opdp1028

Aug 7     Recalls – Class I

               Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA

               Reason for Recall:  Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction (ED) making this product an unapproved new drug.

Aug 7     Recalls – Class II

                Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only.  Manufactured by VistaPharm, Inc., Birmingham, AL 35242.  Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA.

   Reason for Recall:  Failed Impurity/Degradation Specification; "Related Compound C".

   Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only.   Manufactured by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07.                Reason for Recall:    Failed Impurities/Degradation Specifications: unspecified degradation product.

   Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only.   Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. 

   Reason for Recall:  Presence of Foreign Substance: The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

    DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) Liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) Liquicaps Combopack, each 48-count Liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps and 16 NyQuil Sinex NightTime Liquicaps per carton.   Made In Canada, Dist. by Procter & Gamble, Cincinnati, OH 45202, UPC 3 23900 01454 1.

   Reason for Recall:  Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed Liquicaps within the blisters.

    Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Manufactured for: Prasco Laboratories, Mason OH, 45040, USA.   Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30

   Reason for Recall:  Defective Container; this action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.

 Aug 7     Health and Beyond LLC Issues Voluntary Nationwide Recall of Tranquility Product Due to Product Having Traces of Pharmaceutical Ingredients.  The products have been found to contain a trace of Doxepin which is a pharmaceutical for sleep and Chlorpromazine for psychotic disorders.  The product is used as a sleep product and is packaged in a white bottle with 30 pills per bottle with lot # 36678 and 36680.  The affected product in the Tranquility lots includes the following expiration date 9/15.  The product was distributed Nationwide, wholesale, retail and via internet.

Aug 6     Guidance for Industry.  Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.  You can obtain a copy at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269919.pdf?source=govdelivery

Aug 5     Discontinued Tablets – Asenapine (Saphris) Unflavored tablets.  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., has announced that all unflavored tablets will be discontinued.  The Saphris black cherry flavor tablets will remain available.

Aug 5     FDA Announces Fiscal Year 2014 Generic Drug Fees.   As expected the fiscal year 2014 user fees will include an increase over the 2013 fees.  In the first year of the program (2013), the total revenue included a one-time fee for applications pending as of October 1, 2012. With this one-time fee removed from the calculation, the remaining fees make up the total revenue, which resulted in the increase. Additional factors, including the number of facilities that self-identify under GDUFA, are also used in calculating the facility fee.  The domestic facility fee will be $220,152; the ANDA fee will be $63,860; Prior Approval Supplement (PAS) Fee will be $31,930, and the Drug Master File (DMF) fee will be $31,460.  For further details go to:  http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18625.pdf

Aug 5     FDA Announces Fiscal Year 2014 Prescription Drug User Fees (PDUFA).  Application (with clinical data) fees will be $2,169,000.  Application (without clinical data) fees or a supplement with clinical data will cost $1,084,550.  Establishment fees are $554,600 and product fees are $104,060.  Learn more at:  https://www.federalregister.gov/articles/2013/08/02/2013-18624/prescription-drug-user-fee-rates-for-fiscal-year-2014?source=govdelivery&utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov 

Aug 5     Guidance for Industry:  Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.   Learn more at:  http://www.gpo.gov/fdsys/pkg/FR-2013-07-30/pdf/2013-18236.pdf?source=govdelivery

Aug 3     CTV Best Group Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Best Slim 40 Pills Lot # 109400 Expiry Dec. 31, 2016, because of Potential Health Risk.   Testing by the U.S. Food and Drug Administration (“FDA”) revealed the presence of “sibutramine” in Best Slim.  Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

Aug 1     FD Safety Podcast:  FDA Warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen.  On August 1, 2013, the FDA issued a Drug Safety Communication informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens- Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen.  Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.  Listen to the podcast at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm363918.htm?source=govdelivery

Jul 31     Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level. There is a question of sterility assurance for the affected products raised by the FDA.  To see the list go to:  http://www.fda.gov/Safety/Recalls/ucm363284.htm?source=govdelivery

 Jul 31     Recalls – Class II

               Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60. 

Reason for Recall:  Failed Tablet/Capsule Specifications: Broken tablets.

Jul 31    Recalls – Class III

Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a) 100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only.   Manufactured by Watson Laboratories, Inc., Corona, CA92880.  Reason for Recall:  Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Jul 29     Drug Information Update - FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement.  The U.S. Food and Drug Administration has issued a Press Announcement warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.  The FDA has received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50.  These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels.  Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone. 

Jul 26     FDA Drug Safety Podcast: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems.  Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.  Serious liver damage has occurred in patients receiving high doses of Nizoral for short periods of time as well as those receiving low doses for long periods.

Jul 24     Notice to Industry: FDA Issues Draft Guidance for Pre-Launch Importation Requests (PLAIR).  This draft guidance to industry, outlines the agency’s policy on the importation of unapproved finished drug products in anticipation of approval and market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics licensing application (BLA) regulated by FDA’s Center for Drug Evaluation and Research (CDER).  You can read the Federal Register Notice at:         https://www.federalregister.gov/articles/2013/07/24/2013-17768/draft-guidance-for-industry-on-pre-launch-activities-importation-requests-av,, ailability

 

Jul 23     FDA alerts consumers of undeclared drug ingredients in over-the-counter diabetes product.  The U.S. Food and Drug Administration is advising consumers not to purchase or use “Jiang Tang Yi Huo Su Jiao Nang,” a drug product promoted and sold as a diabetes treatment. The product contains three active pharmaceutical ingredients, including one that was removed from the U.S. market because of the risk of serious side effects.  FDA laboratory analysis found that “Jiang Tang Yi Huo Su Jiao Nang” contains the following undeclared potentially harmful active ingredients: glyburide, metformin, and phenformin.  Read more at:  http://www.fda.gov/Drugs/DrugSafety/ucm361618.htm?source=govdelivery

Jul 23     Herbal Give Care LLC Issues Voluntary Nationwide Recall of Esbelin Siloutte Te and Esbelin Siloutte Vitamin Supplement Due to Potential Health Risks.   Grand Prairie, Texas, Herbal Give Care LLC is voluntarily recalling all lots of Esbelin Siloutte Te and Esbelin Siloutte Herbal Blend with L-Carnitine (30 Capsules), to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine.   Because of this, these products may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. 

Jul 22     Volcano Company, Issues Voluntary Worldwide/Nationwide Recall of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients.  Long Beach, CA, Volcano Company is voluntarily recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules to the consumer level. FDA test results revealed the Volcano Male Enhancement Liquid has been found to contain undeclared Desmethyl Carbodenafil, Dimethylsildenafil, and Dapoxetine.

Jul 18     FDA/CDER Small Business Chronicles – The USP Salt Policy.  You can download a copy at:

    http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM360816.pdf?source=govdelivery

Jul 15     Hardmenstore.com Issues Voluntary Nationwide Recall of Silver Sword and Clalis at the Request of the FDA.  Upon request of the FDA, Hardmenstore.com is voluntarily recalling 430 lots of Silver Sword and Clalis at the consumer level. According to representatives of the FDA, Silver Sword and Clalis have reportedly been found to contain amounts of PDE-5 Inhibitor Sildenafil, which could cause adverse reactions and drug interactions normally associated with the active ingredient in Viagra.

Jul 12     Drug Information Update - FDA approves new treatment for a type of late-stage lung cancer.   The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.  Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the Therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations.

 Jul 10     Recalls – Class III

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only and Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only.   Manufactured by Wyeth Pharmaceuticals Inc., Philadelphia, PA. 

               Reason for Recall:  Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

 Jul 9       Draft Guidance for Industry – Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM359184.pdf?source=govdelivery

 

Jul 7       Recalls – Class II

              INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic.   Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com

Reason for Recall:  Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.

 

Jul 5       Sandoz US Announces Voluntary Nationwide Recall of Estarylla.  Princeton, New Jersey, – Sandoz is conducting a voluntary nationwide recall to the retailer level of one lot of its Estarylla (norgestimate and ethinyl estradiol) tablets in the US, following a customer report of a placebo tablet present in a row of active tablets on one pack. Estarylla is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

 

Jul 3       The Rhode Island Department of Health (HEALTH) advises consumers not to eat Mediterranean Olives.  Specifically, Calcidica Sweet (Brand: Bel Frantoio) sold at any Ocean State Job Lot (OSJL) stores. OSJL is voluntarily recalling the product after HEALTH staff discovered that these products were not handled appropriately to prevent production of the toxin that causes botulism.

Jul 1       FDA approves the first non-hormonal treatment for hot flashes associated with menopause.   The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.  There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.  Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be very bothersome, causing discomfort, embarrassment and disruption of sleep.

        

 

                 Specialty Pharma Newsletter (May-June 2013) 

June 28  Voluntary Recall of JaDera and Xiyouji Qingzhi Weight Loss Supplements.  Miami, Florida, Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine.  Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.

June 28  Office of Compliance (OC) and Center for Drug Evaluation and Research (CDER), are excited to announce their first Virtual Hiring Event. You will have the opportunity to meet the Director along with other staff members and learn firsthand about the positions available within OC.  FDA is looking for candidates in the areas of Chemical Engineering, Chemistry, Biology, Microbiology, Pharmacology, Pharmacy, Regulatory Counsel, Consumer Safety Officers and Project Managers. To register for this event, please go the following link:  www.fda.gov/gdufahiring                                                                               The recorded hiring event will be available for viewing for those participants who register, but are unable to attend the event live.  OC encourages all interested candidates to register in advance of the event for consideration.

June 28  Public Notification: “Silver sword” “Strawberry Balance” and “Meizi Evolution” Contain Hidden Drug Ingredients.  These products are promoted and sold for sexual enhancement on various websites and in some retail stores.  FDA laboratory analysis confirmed that Silver sword contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED).   FDA laboratory analysis confirmed that “Strawberry Balance” and Meizi Evolution contain sibutramine.  Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons.  Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

June 27  The USDA Food Safety and Inspection Service has issued a compliance guide that may be helpful to other industries as well.  FSIS is issuing this guidance document to provide criteria to establishments producing meat, poultry, and processed egg products for selecting a commercial or private microbiological testing laboratory to analyze establishment samples.  To download, go to:  http://www.fsis.usda.gov/wps/wcm/connect/464a4827-0c9a-4268-8651-b417bb6bba51/Guidance-Selection-Commercial-Private-Microbiological-Testing-lab-062013.pdf?MOD=AJPERES

 

June 26  Recalls – Drugs – Class III

Sodium Sulfacetaminde 10% and Sulfur 5% Lotion (NDC 42792-102-01).  Manufactured for Austin Pharmaceuticals, LLC, Wilmington, Delaware, by Mission Pharmacal Company has been recalled because the drug product active ingredients were formulated incorrectly (Super potent) with respect to the labeled strength.

 HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only (NDC 50383-796-16).    This product was manufactured by Hi-Tech Pharmacal Company Inc., Amityville, NY.  It has been recalled because it failed stability at 24 months (Sub potent).

 Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only. This product was distributed by G.D. Searle LLC, Division of Pfizer Inc., New York, NY 10017.  It has been recalled because it failed dissolution specification.

 Dr. Sheffield's Triple Antibiotic Ointment Bacitracin 400 units, Neomycin Sulfate 3.5mg, Polymyxin-B Sulfate 5,000 units, First Aid Antibiotic Ointment, Net Wt. 0.33oz (9g).  It was manufactured by Faria Limited LLC d.b.a. Sheffield Pharmaceuticals.  It is being recalled because it failed stability specifications - unable to meet shelf life expiry date.

 Recalls – Drugs – Class II

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a) Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only.   The product was manufactured for Teva Pharmaceuticals by Cephalon, Inc., Salt Lake City, UT 84116.  Product is being recalled due to an out of specification dissolution result (sub-potent drug) during stability testing.

 

 

 

       

June 26 Guidance for Industry

Draft Guidance for industry: Expedited Programs for Serious Conditions--Drugs & BiologicsThe draft guidance will also provide a single source for information on these programs for industry.  In addition, the draft guidance aligns CDER’s criteria for priority review designation with CBER’s criteria (i.e., only products intended to treat a serious condition are eligible for priority review, unless otherwise eligible under specific statutory provisions).  You can obtain a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf?source=govdelivery

Guidance for Industry: Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.  The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.'' This guidance was initially published as draft guidance on February 13, 2012. The draft was revised to clarify FDA's expectations and recommendations and to include references to a recently-developed assay for detecting ruminant contamination of crude heparin.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291390.pdf?source=govdelivery

 Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products.  The Food and Drug Administration is announcing the availability of a guidance entitled ``ANDAs: Stability Testing of Drug Substances and Products.'' FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonization (ICH) guidance Q1A (R2) through Q1E.  The use of these ICH recommendations will standardize FDA's stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient.   Get your copy at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072873.pdf?source=govdelivery

 Guidance for Industry: Co-development of Two or More New Investigational Drugs for Use in Combination.  This guidance is intended to assist sponsors in the co-development of two or more investigational drugs that have not been previously developed for any indication (i.e., ``new investigational drugs'') to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that may arise during co-development of two or more new investigational drugs.  It is not intended to apply to development of combinations of already approved drugs or to development of a single new investigational drug to be used in combination with an already approved drug or drugs. The guidance is not intended to apply to biological products regulated by the Center for Biologics Evaluation and Research or medical devices.  Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf?source=govdelivery     

 

June 26  Warning Letters

A Warning Letter Was Issued to Eva Pharmacy (support@customersupportglobal.com; VisitSupportPage@hotmail.com; Jennaiyyek@hotmail.com; viviyanrydky@hotmail.com.)   After reviewing their websites, the FDA determined that their websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Specifically, these products are new drugs within the meaning of FD&C Act and are not recognized as safe and effective and consequently are “Misbranded and Unapproved Drugs”.

June 21 Drug Information Update - FDA obtains waiver from European Commission to facilitate export for U.S. pharmaceutical manufacturers.  The U.S. Food and Drug Administration announced today that the U.S. is now a “listed” country with the European Commission (EC) so that U.S. companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.  Without the waiver, all U.S. companies shipping active pharmaceutical ingredients (APIs) to Europe after July 1, 2013 would have had to first submit documentation from the FDA that the product was manufactured in accordance with Europe’s good manufacturing practices.  To avoid that burden for companies, the FDA filed a formal “listing request” with the EC in January 2013 that the FDA’s good manufacturing practices be considered at least equivalent to those in Europe.

June 20  Sage Pharmaceuticals, Inc., Shreveport, Louisiana, has been cited for violation of the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products.  This is the second injunctive case that the government has brought against Sage alleging the distribution of unapproved new drugs.  In 2000, the government obtained an injunction against the company banning the manufacture and distribution of two unapproved new drugs.  Since that time, FDA inspections revealed that defendants continue to manufacture and distribute other drug products—including prescription pain relievers, over-the-counter (OTC) cough and cold remedies, and OTC wound cleansers—without first obtaining the requisite FDA approvals.  As a result, the defendants’ products are unapproved new drugs and misbranded drugs under the FDCA, and potentially unsafe and ineffective.   The Justice Department will seek a permanent injunction requiring the defendants to cease all receiving, processing, manufacturing, preparing, packaging, labeling, holding, and distributing activities until they comply with applicable FDA regulations.  

June 20  Beta Labs, LTD Announces a Recall of Dietary Supplements Oxyphen, Phentalene, Phen FX, and Red Vipers Due to Possible Health Risk.  The recall was initiated on June 15, 2013, after a review of recent FDA communications related to 1,3 dimethylamylamine (“DMAA”). The Products contain DMAA.  The UPC codes for each of the products are: Oxyphen XR, 70541 59974; Phentalene, 70541 59982; Phen FX, 29882 55980; Red Vipers, 29882 55981. The Products are all in capsule form. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health.  Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.             

June 19  Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets. The recall was first initiated on June 17, 2013, after a complaint was received concerning a bottle labeled as Enteric Coated Aspirin Tablets, 81 mg, actually containing Acetaminophen 500 mg tablets.  Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg)!  The lot was manufactured and packaged by Advance Pharmaceutical Inc., Holtsville, NY, under the label of Rugby Laboratories, Inc., Duluth, Georgia 30097. 

June 19  Recalls – Drugs – Class I                                                                                                                       Rugby Natural Iron Supplement Ferrous Sulfate, 5 gr (325 mg), 100 Tablets.  Manufactured for: Rugby Laboratories, Inc., Duluth, Georgia 30097.  Manufactured by Advance Pharmaceutical, Inc., Holtsville, Georgia (UPC 0 0536-5890-013).  Reason: Labeling; Label Mix-up; bottles of Ferrous Sulfate actually contain Meclizine Hydrochloride (indicated for motion sickness).

June 19  Recalls – Drugs – Class III                                                                                                            Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL).  Manufactured by Teva Pharmaceuticals USA, Inc., Sellersville, PA.  Reason for recall:  Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.                 

June 18   FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate).  The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).  Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

 June 12  Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets.  Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.  The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

 June 11  Guidance for industry: “Contract Manufacturing Arrangements for Drugs: “Quality Agreements”.  This guidance describes FDA’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to current Good Manufacturing Practice (cGMP). In particular, the guidance describes how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM353925.pdf?source=govdelivery

 June 11 Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers Guidance Documents.  FDA has made available two draft guidance for industry entitled, “Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers,” and “Charging for Investigational Drugs Under an Investigational New Drug Application – Questions and Answers.”  These two guidance documents are intended to provide information about certain aspects of regulations on expanded access to investigational drugs for treatment use, and to provide information on the agency’s regulation on charging for an investigational drug under an investigational new drug application. The Expanded Access document can be found at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351261.pdf?source=govdelivery                                                                                                                           The Charging for Investigational Drugs document can be found at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351264.pdf?source=govdelivery

June 11  Draft Guidance for Industry on Rheumatoid Arthritis: Developing Drug Products for Treatment.  This guidance outlines FDA's current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for drug products developed as drug-device combination products. This guidance revises the guidance for industry entitled “Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA),” published in February 1999.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM354468.pdf?source=govdelivery

June 5    Recalls – Drugs – Class II                                                                                                                                Ropinirole hydrochloride tablets, USP 4 mg, 100-count bottle (NDC 0378-5504-01), Rx only. Manufactured for Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.  Made in India.  Reason for recall: Labeling - Label Error on Declared Strength - Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..       

June 5    Recalls – Drugs – Class III                                                                                                                            Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01.   Manufactured for Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810.  Manufactured by Aurobindo Pharma Limited, Hyderabad- 500 072 India.  Reason for recall: Labeling - Label Error on Declared Strength - Incorrect strength on side display panel of label.

June 5    Guidance for Industry:  Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.  You can obtain a copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf?source=govdelivery  

June 3    FDA Drug Safety Podcast: FDA Recommends Against Prolonged Use of Magnesium Sulfate to Stop Pre-term Labor Due to Bone Changes in Exposed Babies.  Magnesium sulfate is approved to prevent seizures in preeclampsia, a condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia.  Preeclampsia can lead to eclampsia, seizures, stroke, multiple organ failure, and death of the woman and/or baby.  Use of magnesium sulfate injection to pregnant women longer than 5 to 7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones, called osteopenia, and bone breaks, called fractures.  The shortest duration of treatment that can result in harm to the baby is not known.   A podcast on this subject is available at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm354762.htm?source=govdelivery

 May 30  FDA announces import of injectable nutrition drugs.  This action addresses shortages of drugs needed to treat premature infants and patients unable to eat or drink by mouth.  The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.  TPN is an intravenous food solution containing several drugs that have been in short supply, including  trace elements, potassium phosphate, and sodium phosphate. Hospitals nationwide rely on TPN.  "While we have made progress on the critical issue of drug shortages, we remain extremely concerned about all current and potential drug shortages, and we are vigilant in our efforts so patients have access to the medicines they need, when they need them,” said FDA Commissioner Margaret A. Hamburg, M.D.  The FDA is exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need.  The shortages are largely the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012.

May 30  MRSA study: simple steps slash deadly infections in sic, ,, kest hospital patients.  A new study on antibiotic-resistant bacteria in hospitals shows that using germ-killing soap and ointment on all intensive-care unit (ICU) patients reduced bloodstream infections by up to 44 percent in 74,000 patients and significantly reduced the presence of methicillin-resistant Staphylococcus aureus (MRSA). Patients who have MRSA present on their bodies are at increased risk of developing a MRSA infection and can spread the germ to other patients.

 May 29  Recalls – Class II                                                                                                                             Numerous lots of levothyroxine sodium tablets at various strengths (approximately 30 items) are being recalled.  The tablets were manufactured for Forest Pharmaceuticals, Inc., St Louis, Missouri, by Lloyd Pharmaceutical, Shenandoah, Iowa.  Reason for recall: cGMP deviations.  After a quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only are being recalled.  They were manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV 26505, and packaged and distributed by UDL Laboratories, Inc., Rockford, IL 61103, NDC 51079-020-03.  The recalling firm is Mylan Institutional, Inc., d.b.a. UDL Laboratories.

May 29 FDA approves two drugs, companion diagnostic test for advanced skin cancer.   The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.  Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimates 76,690 Americans will be diagnosed with melanoma and 9,480 will die from the disease in 2013.                                                                                                                                             The most serious side effects reported in patients receiving Tafinlar included an increased risk of skin cancer (cutaneous squamous cell carcinoma), fevers that may be complicated by hypotension (low blood pressure), severe rigors (shaking chills), dehydration, kidney failure and increased blood sugar levels requiring changes in diabetes medication or the need to start medicines to control diabetes.  The most common side effects reported in patients receiving Tafinlar included thickening of the skin (hyperkeratosis), headache, fever, joint pain, non-cancerous skin tumors, hair loss and hand-foot syndrome.                                                                                                                                                The most serious side effects reported in patients receiving Mekinist included heart failure, lung inflammation, skin infections and loss of vision. Common side effects included rash, diarrhea, tissue swelling (peripheral edema) and skin breakouts that resemble acne.

 May 28  Guidance for Industry:  Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in ICH Regions Annex 13 Bulk Density and Tapped Density of Powders General Chapter.   Download at:   http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM218825.pdf

 May 21  DA/CDER Small Business Chronicles – BsUFA.  The topic of this month’s issue of the FDA/CDER Small Business Chronicles is the Biosimilar User Fee Act of 2012 (BsUFA).  In this issue, FDA discusses the background of BsUFA, performance goals, and associated fees.  Download at:  http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM353388.pdf?source=govdelivery

May 15  FDA approves Simponi to treat ulcerative colitis.  The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.  Simponi works by blocking tumor necrosis factor (TNF), which plays an important role in causing abnormal inflammatory and immune responses.  Previously approved to treat rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis (arthritis affecting the joints in the spine and the pelvis), Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.  Ulcerative colitis is a chronic disease that affects about 620,000 Americans. It causes inflammation and ulcers in the inner lining of the large intestine and is one of two main forms of chronic inflammatory bowel disease.

May 15  Recall –Drugs – Class III

   Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle.  Distributed by Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01.  Manufactured by L. Perrigo Company, Allegan, Michigan.  Reason:  Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing.

 May 15  The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.  Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013.

May 14  FDA approves Nymalize—first nimodipine oral solution for use in certain brain hemorrhage patients.  New oral formulation may help reduce potentially fatal medication errors.  On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.  “Having an oral version of this product may help reduce the medication errors we’ve seen from erroneous intravenous administration of the contents of oral capsules,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Nymalize is a liquid that is administered orally, or via nasogastric tube or gastric tube, and there is no need for a needle to be used, which is what caused past medication errors.”

 May 9    Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors.  The purpose of this guidance is to help prescription drug and biologic product manufacturers minimize medication errors associated with their products. This guidance focuses on safety aspects of the container label and carton labeling design, and provides a set of principles and recommendations for ensuring that critical elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product.   Download your copy at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf?source=govdelivery

 May 8    Recall – Drugs – Class III

 Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, 90 count bottle (NDC#: 0430-0145-23), Rx only,

 Jevantique (norethindrone acetate and ethinyl estradiol) tablets; 1.0 mg/5.0 mcg, 90 count bottle (NDC# 52544-237-19),

  Femhrt (norethindrone acetate and ethinyl estradiol) tablets, 1.0 mg/5.0 mcg, 90 count bottle (NDC#: 0430-0544-23),

   Manufactured by Warner Chilcott Company, LLC, Fajardo, PR 00738.  Marketed by Warner Cholcott (US), LLC, Rockaway, NJ 07866.  Reason for recall - Chemical contamination - Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.

 May 7    Public Notification: FDA is Advising Consumers Not To Purchase Vicerex, Bullet Proof, and Lightning Rod.  FDA Laboratory analysis confirmed that these products contain tadalafil, the active ingredient in the FDA-approved prescription drug Cialis, used to treat Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

 May 2    Recalls – Drugs – Class II

 Gilmepiride Tablets, USP, 2 mg, 100-count tablets per bottle, Rx only.   Manufactured for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21.  Reason for recall - Failed Tablet/Capsule Specifications - One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

 Apr 25   Public Notification:  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Sex Plus,” a product promoted and sold for sexual enhancement on various websites and in some retail stores.  FDA laboratory analysis confirmed that “Sex Plus” contains undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil. Sulfosildenafil and dimethylacetildenafil are structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED).  Tadalafil is the active ingredient in Cialis, also an FDA approved prescription drug for ED.  These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

 Public Notification:  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Zoom-Zooma-Zoom,” a product promoted and sold for sexual enhancement on various websites and which may be sold in retail stores.  FDA laboratory analysis confirmed that “Zoom-Zooma-Zoom” contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat Erectile Dysfunction (ED).  This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. 

 Apr 24   Recalls – Drugs – Class II

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62).  Packaged by Precision Dose, Inc., S. Beloit, IL 61080.  Reason for recall: Labeling - Not Elsewhere Classified. This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

 Levoxyl (levothyroxine sodium) tablets, USP. 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, and 200 mcg packaged in 100-count bottles and/or 1000 count bottles, Rx only. Manufactured and Distributed by King Pharmaceuticals, Inc., Bristol, TN 37620.  Recalling firm:  Pfizer, Inc., New York, NY.   Reason for recall - Chemical contamination - Emission of strong odor after package was opened.

 Apr 24   Recalls – Drugs – Class III

 buPROPion Hydrochloride Extended-Release Tablets (XL) 300 mg, 30-count tablets per bottle, Rx only.  Distributed by Actavis South Atlantic LLC, Sunrise, FL 33325.  Packaged by American Health Packaging, Columbus, OH 43217.  Reason for recall - Failed USP Dissolution Test Requirements  -  Out-of-specification dissolution results at the 8 hour stability testing point.

Apr 17   Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products.  This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product. This guidance finalizes the draft guidance issued on September 19, 2011.  To obtain a copy, go to:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM272122.pdf?source=govdelivery

 Apr 16   FDA Actions on OxyContin Products.  FDA has determined that the reformulated version of OxyContin has abuse-deterrent properties and has approved new labeling that indicates that the product has physical and chemical properties that are expected to make abuse by injection difficult and to reduce abuse via the intranasal route.  FDA also has determined that Purdue Pharma’s original formulation of OxyContin was withdrawn from the market for safety reasons. As a result, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of these products. 

Apr 12   Affirm XL, Inc., Issues a Voluntary Nationwide Recall of Affirm XL Dietary Supplement Tablet, Lot 1190001 Due to Potential Health Risk.  Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for this product.

Apr 11   Green Valley Drugs: Recall of All Lots of All Sterile Products - Quality Control Concerns.  Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. A full list of the recalled products (name, lot # and Beyond Use date) is linked from the press release or can be accessed at greenvalleymed.com.  Green Valley Drugs sterile products covered under this recall were distributed nationwide.  The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques. Green Valley has received no reports of injury or illness associated with the use of the products.  Until further notice, healthcare providers should stop using all lots of sterile products and return them to the company.

 Apr 10   Recalls – Drugs – Class II

  Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only.  Distributed by Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807.  Recalling firm is Dr. Reddy’s Laboratories Tennessee, LLC.   Reason for recall: Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.

 Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only.   Manufactured  for: Versapharm Incorporated, Marietta, GA; Manufactured by West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.  Reason for recall - Sub potent Drug - Out Of Specification results for assay at the stability time-point of 24 months.

 Recalls – Drugs – Class III

Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only.  Manufactured by Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.  Reason for recall - Labeling Illegible - There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

 Apr 9     New web-based learning course-“Electronic Common Technical Document (eCTD): Overview and Submission”.  FDA/CDER’s Small Business Assistance Program announces the launch of its first CDERLearn web-based learning courses.   It will address the essential steps of submitting electronic submissions to CDER, and is a great resource for questions about the submission process.  Take the course at:  http://www.accessdata.fda.gov/scripts/cder/training/eCTD/index.htm?source=govdelivery

                 Specialty Pharma Newsletter (March 2013)

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

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

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

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

Apr 3     Recalls – Class II

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

Apr 3     Guidance for Industry

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

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

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

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

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

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

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

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

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

Apr 1     Guidance for Industry

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

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

Mar 27   Recalls – Drugs Class III

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

 Mar 27   Recalls – Drugs Class II

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

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

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

Mar 22  Warning Letter

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

Mar 19   Recalls – Class II

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

Pharmaceutical Pollution Concern around the World

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

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

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

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

Tackling the Problem

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

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

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

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

For more information regarding this article, please see link:

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

 

 

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

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

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

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

Mar 6     Recalls – Class II

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

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

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

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

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

And

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

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

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

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

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

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

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

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

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

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

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

Feb 19    Discontinued Drugs

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

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

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

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

 Feb 13    Enforcement Report

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

Feb 11 Warning Letters

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

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

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

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

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

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

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

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

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

 Feb 6      Recalls – Class I

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

Feb 6      Recalls – Class II

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

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

Feb 5      Drugs to be Discontinued

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

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

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

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

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

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

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

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

Jan 30    Recalls – Class II

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

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

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

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

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

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

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

Jan 25    Warning Letters

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

Current Good Manufacturing Practice (cGMP) violations for dietary supplements

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

Current Good Manufacturing Practice (cGMP) violations for sterile products

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

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

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

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

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

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

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

Jan 9      Recalls – Class II

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

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

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

Jan 7      FDA Issues Two New Guidance Documents.

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

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

Jan 4      Guidance for Industry. 

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

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

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

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

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

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

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

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

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

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

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

Specialty Pharma Newsletter (October-November 2012)

Nov 21   Recalls – Class II 

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

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

Nov 21   Recalls – Class III

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

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

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

Additional information on self-identification is available at:

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

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

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

This guidance can be downloaded at:  

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

Nov 7     Recalls – Class II

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

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

 Nov 6     Warning Letters

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

Nov 2     Warning Letters  

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

Nov 2     Recalls – Class II 

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

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

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

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

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

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

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

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

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

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

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

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

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

Oct 24    Recalls – Class III 

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

Recalls – Class II  

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

Oct 23    Warning Letters

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

Oct 22   Warning Letters

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

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

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

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

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

Oct 17    Recalls – Class III

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

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

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

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

 Oct 10    Recalls – Class II 

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

Oct 10    Recalls – Class III

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

Oct 9      Warning Letters  

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

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

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

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

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

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

Oct 5      Warning Letters 

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

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

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

 Specialty Pharma Newsletter (September 2012)

Oct 5      Guidance For Industry

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

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

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

Oct 4      Guidance For Industry

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

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

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

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

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

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

Oct 3      Warning Letters Issued to:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Aug 23   Guidance For Industry

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

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

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

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

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

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

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

You can download this guidance at: 

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

Aug 17   Prescription Drug User Fees for 2013

               Fee category                              Fee rates for FY 2013

               Applications:

               Requiring clinical data                                          $1,958,800

               Not requiring clinical data                                         979,400

               Supplements requiring clinical data                         979,400

               Establishments                                                                526,500

               Products                                                                             98,380

You can find more detail in the Federal Register at:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Jul 18 Enforcement Report - Recalls

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

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

Class II

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

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

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

Class II

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

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

Jul 20 Enforcement Report – Recalls

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

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

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

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

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

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

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

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

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

July 5 Enforcement Report – Recalls

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

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

Class II

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

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

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

Class II

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

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

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

Class II

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

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

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

Class II

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

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

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

Class II

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

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

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

Class II

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

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

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

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

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

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

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

Jun 27 Enforcement Report – Recall

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

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

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

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

Jun 13 Enforcement Report – Recalls

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Jun 6      Recalls: Drugs - Class III

PRODUCT

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

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON                                                                                                                                                

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

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

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

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

May 30  Drugs to be Discontinued: 

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

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

 May 30  Recalls: Drugs – Class I

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

May 30  Recalls: Drugs - Class II

PRODUCT 

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

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

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

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

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

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

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

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

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

May 16  Recalls: Drugs – Class II

PRODUCT

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

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

May 16  Recalls: Drugs – Class III

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

May 9    Recalls and Field Corrections: Drugs – Class II

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

Manufacturers: Merck Sante, Semoy, France;

Forest Pharmaceuticals Inc., Cincinnati OH.

Firm initiated recall is ongoing.

REASON                                                                                                                                                 

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

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

May 9    Recalls: Drugs - Class III

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

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

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

Apr 25   Recalls Pending Classification: Drugs

PRODUCT

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

RECALLING FIRM/MANUFACTURER

Recalling Firm: Quadrant Chemical Corporation, Garland, TX

Manufacturer: Quadrant Chemical Corporation, Garland, TX

REASON FOR RECALL

Subpotent (Single Ingredient) Drug: zinc pyrithione

PRODUCT

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

Lot # 34000741A; Expiration date: 7/2013

RECALLING FIRM/MANUFACTURER

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

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

REASON FOR RECALL

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

PRODUCT

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

All Lots

RECALLING FIRM/MANUFACTURER

Recalling Firm: XR Industries LLC, Pompano Beach, FL

Manufacturer: CRM Laboratories, Marathon, FL

REASON FOR RECALL

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

PRODUCT

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

G00921A, G00922A & G00923A, Exp Aug 2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Actavis Totowa LLC, Totowa, NJ

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

REASON FOR RECALL

Presence of Foreign Substance; product may contain magnesium stearate

Apr 25   Recalls And Field Corrections: Drugs – Class II

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

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

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

Lots Too Numerous To Mention

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

Apr 18   Recalls Pending Classification: Drugs

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

Manufacturer: Barr Laboratories Inc, Pomona, NY

REASON FOR RECALL

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL

REASON FOR RECALL

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

Recalls and Field Corrections: Drugs – Class I

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

Apr 18   Recalls and Field Corrections: Drugs – Class II

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

Manufacturer: Sandoz Inc., Wilson, NC

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

Apr 17    Recalls Pending Classification: Drugs

PRODUCT

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

 RECALLING FIRM/MANUFACTURER

 Recalling Firm: Sandoz Incorporated

Manufacturer: Sandoz Private Limited

REASON FOR RECALL

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ

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

REASON FOR RECALL:

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

Apr 4     Recalls and Field Corrections: Drugs – Class II

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

Defective Container: Recall Due to Dosing System Complaints.

PRODUCT

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

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

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

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

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

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

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

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

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

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

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

Mar 21   Recalls Drugs Awaiting Classification

PRODUCT

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

CODE

Approximately 30 lots

RECALLING FIRM/MANUFACTURER

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

Manufacturer: Corepharma LLC, Middlesex, NJ

REASON FOR RECALL

Impurities/Degradation Products

PRODUCT

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

CODE

Lot number: BT0643, Exp Date 06/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sandoz, Inc. Princeton, NJ

Manufacturer: Sandoz Pharmaceuticals, Wilson, NC

REASON FOR RECALL

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

Recalls Drugs Class II

PRODUCT

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

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

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

CODE

Numerous

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

CODE

Lot Number: 6C0074 Expiration June 2013

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

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

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

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

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

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

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

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

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

Mar 14   Recalls Class III

PRODUCT  

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

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

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

Mar 14   Recalls Class III

PRODUCT  

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

Mar 14   Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice Public Hearing  The Food and Drug Administration (FDA) is announcing a 2-day public hearing to obtain input from interested persons on FDA's scope and direction in modernizing the regulations, policies, and practices that apply to the conduct of clinical trials of FDA-regulated products.

The purpose of this hearing is to solicit public input on FDA’s efforts to modernize the regulatory framework that governs clinical trials and approaches to good clinical practice (GCP), including encouraging the use of innovative models that may enhance the effectiveness and efficiency of the clinical trial enterprise. Date(s): April 23-24, 2012    Time: 8:30 a.m. to 4:30 p.m.  Location: FDA White Oak Campus, 10903 New Hampshire Ave.  Building 31, Room 1503 Silver Spring, Maryland 20993

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

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

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

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

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

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

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

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

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

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

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

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

 Feb 29    Recalls Class I

 PRODUCT

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

CODE

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

Feb 29    Recalls Class II

 PRODUCT

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

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

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

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

CODE

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

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

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

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

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

CODE

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

2) Lot # 16T020, exp 1/2012

RECALLING FIRM/MANUFACTURER

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

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

REASON

Impurities/Degradation Products: High OOS results for Impurity.

PRODUCT

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CODE

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

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

CODE

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

PRODUCT

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

CODE

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

RECALLING FIRM/MANUFACTURER

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

Manufacturers: Actavis South Atlantic LLC. Sunrise, FL;

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

REASON

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

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

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

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

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

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

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

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

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

Feb 22   Recalls – Drugs Class II

PRODUCT

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

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

CODE

Too numerous to mention here.

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

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

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

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

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

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

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

Feb 8      Recalls – Drugs Class III 

               PRODUCT

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

CODE

Lot: C081196

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

Jan 25   Recalls – Drugs Class II

               PRODUCT

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

CODE

Lot BR7539

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

PRODUCT

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

CODE

Lot BR7539

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

Jan 19    Recalls – Class II

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

Subpotent; 24 month stability time point.

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

Failed USP Dissolution Test Requirements (below specification). 

Jan 17    Warning Letters:

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

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

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

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

               Call in numbers (listen only):

                        Domestic: 1-888-946-6301

                        International: 1-312-470-0190

                        Password (verbal): FDA

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

                        Click on Workshops and Webinars in Spotlight box

Jan 12    Drug Shortages:

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

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

Jan 12    Recalls – Class II

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

            RECALLING FIRM/MANUFACTURER

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

            REASON

            Subpotent (Multiple Ingredient Drug) 

Jan 12    Recalls – Class III

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

               RECALLING FIRM/MANUFACTURER

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

               REASON

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

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

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

               RECALLING FIRM/MANUFACTURER

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

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

               REASON

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

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

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

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

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

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

               Including the following products:

               Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII

               Opana (oxymorphone hydrochloride) CII

               Oxymorphone hydrochloride Tablets CII

               PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII

               PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII

               ENDOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII

               ENDODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII

               MORPHINE SULFATE Extended-Release Tablets CII

               ZYDONE (hydrocodone bitartrate/acetaminophen tablets, USP) CIII

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

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

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

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

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

               Lot 09G005;

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

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

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

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

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

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

               RECALLING FIRM/MANUFACTURER

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

               REASON

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

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

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

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

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

Dec 28               Recalls – Class II 

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

               RECALLING FIRM/MANUFACTURER

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

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

               REASON

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

               PRODUCT

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

               RECALLING FIRM/MANUFACTURER

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

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

               REASON

               Presence of Particulate Matter.

Dec 28   Recalls – Class III

               PRODUCT

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

               RECALLING FIRM/MANUFACTURER

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

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

               REASON

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

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

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

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

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

Dec 14   Recalls – Drugs Class II

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

               RECALLING FIRM/MANUFACTURER

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

               REASON

               Impurities/Degradation Failure; 18 month time point.

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

               RECALLING FIRM/MANUFACTURER

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

               REASON

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

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

               RECALLING FIRM/MANUFACTURER

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

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

               REASON

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

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

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

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

Dec 7     Recalls – Drugs Class II

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

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

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

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

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

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

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

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

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

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

CODE:  Numerous lots

RECALLING FIRM/MANUFACTURER

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

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

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

REASON

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

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

RECALLING FIRM/MANUFACTURER

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

REASON

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

Dec 7     Recalls:  Drugs – Class III 

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

RECALLING FIRM/MANUFACTURER

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

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

REASON

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

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

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

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

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

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

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

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

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

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

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

Nov 18   Warning Letters: 

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

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

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

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

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

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

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

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

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

Nov 7     Recalls – Drugs –  II 

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

REASON

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

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

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

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

Nov 2     Recalls – Class II

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

REASON

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

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

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

Oct 26    Recalls

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

REASON

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sep 23   Warning Letters

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

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

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

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

Aug  9 Enforcement Reports

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

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

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

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

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

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

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

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

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

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

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

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

June 21  Drug Shortage – Levorphanol 2 mg Tablets.  Roxane Laboratories has indefinitely discontinued this product.

June 21  Recalled Products:                                                                                                                                            1) Ropinirole Hydrochloride Tablets in 3 mg, 4 mg, and 5 mg strengths recalled by CorePharma, Middlesex, NJ, due to incorrect (obsolete) version of package outsert.                                                          2) Methylprednisolone Tablets in 4 and 8 mg strengths recalled by Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD because products may contain soft or low weight tablets.

June 20  Ortho-McNeil-Janssen Pharmaceuticals, Inc. Voluntarily Recalls One Lot of Risperdal Tablets and One Lot of Risperidone Tablets.  Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).  TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. In January 2010, the company instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to certify that they do not use pallets made from chemically-treated wood.  The RISPERDAL® lot - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. The risperidone lot - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.

 

Package Description

NDC Code

Lot Number

Expiry

RISPERDAL® (risperidone) Tablets
3mg Bottles of 60 Tablets

50458-330-06

0GG904

May 2012

Risperidone Tablets
2mg Bottles of 60 Tablets

50458-593-60

0LG175

August 2012

RISPERDAL® (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years.  RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania.  RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children ages 5-16.

June 20 FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings.  FDA's Center for Drug Evaluation and Research (CDER) recently learned that there have been recent instances when clouding and flavoring agents, which have been used outside the U.S. in certain food manufacturing processes, contain undeclared phthalate plasticizers, specifically diethylhexyl-phthalate (DEHP) and diisononyl-phthalate (DINP).  CDER is not aware at this time of any intentional phthalate substitution, in part or whole, in finished pharmaceuticals or pharmaceutical ingredients used in the U.S. market. Nonetheless, significant overlap of global food and pharmaceutical ingredient supply chains raises the potential for adulterated food ingredients to enter the U.S. pharmaceutical supply chain.  CDER advises manufacturers of drug products and suppliers of pharmaceutical ingredients, both in the U.S. and abroad, to be aware of the potential substitution of phthalate plasticizers for vegetable oils in clouding and flavoring agents.  Manufacturers using emulsions containing vegetable oils should exercise caution to prevent the use of ingredients that might be intentionally adulterated with phthalates.  Please find CDER’s recommendations to pharmaceutical manufacturers and compounding pharmacies at the following webpage: http://www.fda.gov/Drugs/DrugSafety/ucm259844.htm 

June 15  FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer.  The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.  More information at:  http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm

June 15  Guidance for Industry:  Enforcement Policy – OTC Sunscreen Drug Products Marketed Without and Approved Application.  OTC sunscreens are not yet the subject of an effective final monograph, ; however, OTC sunscreens marketed without approved applications and containing specified active ingredients in section II of this guidance are subject to a final rule issued in 2011 that establishes labeling and testing requirements.  To download the guidance, go to:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259001.pdf           

June 14  Guidance for Industry and Investigators:  Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies.  Download at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM257976.pdf

June 13  FDA Approves Potiga to Treat Seizures in Adults.  Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults. Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.  The most common adverse reactions reported by patients taking Potiga in clinical trials included: dizziness, fatigue, confusion, spinning sensation (vertigo), tremor, problems with coordination, double vision, problems paying attention, memory impairment, lack of strength, and double-vision. Potiga can cause urinary retention, generally within the first six months of treatment, although it can also occur later. Because of the risk of urinary retention, urologic symptoms, such as the inability to start to urinate, weak urine stream, or pain with urination, should be carefully monitored. Urinary retention is a unique side effect among the medications used to treat seizures.  Potiga may cause neuro-psychiatric symptoms, including confusion, hallucinations, and psychotic symptoms. When Potiga is discontinued, these symptoms usually resolve within seven days. Like other antiepileptic drugs, Potiga may cause suicidal thoughts or actions in a very small number of people. Patients should contact their health care professional right away if they have thoughts about suicide or dying, new or worsened anxiety or depression, or other unusual changes in behavior or mood. 

June 10  FDA Approves Redesigned Labels for Some Merck Drugs.  The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.  Drugs affected by the revisions include: Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258725.htm

June 9    HHS toolkit of public health emergency text messages now available.  A new toolkit of prepared cell phone text messages advising people how to protect their health after a disaster is available now through the U.S. Department of Health and Human Services. These messages support state and local emergency managers in disaster response and are available online at http://emergency.cdc.gov/disasters/psa.

June 9    Draft Guidance for Industry:  Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.  This document is being distributed for comment purposes only.  Read it at:  http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm

June 9    FDA Works to Lessen Drug Shortage Impact.  Last year, the number of drug shortages in the U.S. reached a record high, and the medicine scarcities have continued at a rapid pace in 2011. The shortages include cancer drugs, anesthetics used in surgery, and "sterile injectables"--medicines given by injection or intravenously. There have also been shortages of medicines that Americans take by mouth each day.  The Food and Drug Administration is doing what it can to prevent and lessen the severity of the shortages, so patients can continue to receive the medicines they need. To find out what to do if your medicine is in short supply, visit http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm258152.htm.  

June 9 Guidance for Industry: Citizen Petitions and Petitions for Stay of Action subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.  Download at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079353.pdf

June 8    FDA Recommends Limiting use of 80 mg Simvastatin.  The Food and Drug Administration is recommending that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury.  FDA says this dose should only be used by patients who have been taking it for 12 months or longer without ill effect.  The overall goal is to get doctors to not start patients on 80 mg of simvastatin, if health care professionals find that patients now taking 40 mg of simvastatin aren’t meeting their LDL cholesterol goal, FDA is advising them to choose a different statin rather than raising the simvastatin dose to 80 mg, says Amy Egan, M.D., deputy director for safety in the FDA division.  Read more at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257884.htm

June 2    Thermogram No Substitute for Mammogram.  Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.  Despite widely publicized claims to the contrary, thermography should not be used in place of mammography for breast cancer screening or diagnosis.  The Food and Drug Administration (FDA) says mammography— an X-ray of the breast—is still the most effective way of detecting breast cancer in its earliest, most treatable stages.  Details at:  http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257499.htm

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

Jul 29     The USDA’s Food Safety and Inspection Service (FSIS) Is Issuing A Public Health Alert For Frozen or Fresh Ground Turkey Products.  This public health alert was initiated after continuous medical reports, ongoing investigations and testing conducted by various departments of health across the nation determined there is an association between consumption of ground turkey products and an estimated 77 illnesses reported in 26 states.  FSIS reminds consumers of the critical importance of following package cooking instructions for frozen or fresh ground turkey products and general food safety guidelines when handling and preparing any raw meat or poultry. In particular, while cooking instructions may give a specific number of minutes of cooking for each side of the patty in order to attain 165 °F internal temperature, consumers should be aware that actual time may vary depending on the cooking method (broiling, frying, or grilling) and the temperature of the product (chilled versus frozen) so it is important that the final temperature of 165 °F must be reached for safety. Please do not rely on the cooking time for each side of the patty, but use a food thermometer.  Consumption of food contaminated with Salmonella can cause salmonellosis, one of the most common bacterial foodborne illnesses. Salmonella infections can be life-threatening, especially to those with weak immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy. The most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.

Jul 29    HHS Awards 71.3 Million To Strengthen Nursing Workforce   HHS announced today $71.3 million in grants to expand nursing education, training and diversity.  Nursing workforce development programs, reauthorized by the Affordable Care Act and administered by HHS’ Health Resources and Services Administration, are the primary source of federal funding for nursing education and workforce development.  These programs bolster nursing education at all levels, from entry-level preparation through the development of advanced practice nurses.  They also prepare faculty to teach the nation’s future nursing workforce. The HHS Secretary was quoted as saying, “These awards reflect the critical role of nurses in our healthcare system, and our ongoing commitment to attract and retain highly-skilled nurses in the profession”.  Awards include:

Nurse Education, Practice, Quality and Retention ($10.9 million – 33 awards)                                                     Nursing Workforce Diversity ($3.6 million – 11 awards)                                                                           Nurse Faculty Loan Program ($23.4 million – 109 awards)                                                                        Advanced Nursing Education Program ($16.1 million – 55 awards)                                                          Advanced Education Nursing Traineeships ($16 million – 349 awards)                                                    Nurse Anesthetist Traineeships ($1.3 million – 76 awards)

Jul 27     Draft Guidance for Industry – 510(k) Device Modifications:  Deciding When to Submit a 510(k) for a Change to an Existing Device.   The U.S. Food and Drug Administration today issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.  The 510(k) process is the most common review path to market for lower-risk medical devices. To legally market a device, manufacturers must submit a premarket notification or 510(k) demonstrating that the new or modified product is substantially equivalent to another legally marketed medical device.  Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.  This document can be downloaded at:  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm265274.htm

Jul 26     Enforcement Reports - Drug Recalls

1. Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, by recall notifications, dated May 5,                         2011.

Manufacturer: Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals, Huntsville, AL. Firm initiated recall is ongoing.

Products:  1) Q-Tussin DM (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-0855-58; UPC 3 0603-0855-58 1. Recall # D-714-2011;

2) CODITUSS DM liquid (Dextromethorphan HBr, USP, 10 mg per 5 mL; Phenylephrine HCl, 5 mg per 5 mL; Pyrilamine Maleate, 8.33 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0728-54; UPC 3 0603-0728-54 0. Recall # D-715-2011;

3) Q-Tapp liquid (Brompheniramine maleate, USP, 1 mg per 5 mL; Dextromethorphan HBr, USP, 5 mg per 5 mL; Pseudoephedrine HCl, USP, 15 mg per 5 mL), 4 fl oz (118 mL) bottle; NDC # 0603-0852-94; UPC 3 0603-0852-94 8. Recall # D-716-2011

4) Iophen DM-NR (Dextromethorphan HBr USP, 10 mg per 5 mL and Guaifenesin, USP, 100 mg per 5 mL) liquid, 16 fl oz (473 mL) bottle; NDC # 0603-1330-58; UPC 3 0603-1330-58 2. Recall # D-717-2011

Lot codes:            1) Lot #: L145C10A, L028C10A; Exp 04/12;

2) Lot #: L089C10A, L089C10B, Exp 04/12;

                                         3) Lot #: L090C10A, Exp 04/12;

4) Lot #: L099D10A, L107C10A, L115C10A, Exp 05/13

Reason:   CGMP Deviations: These products have been manufactured with a lot of dextromethorphan   which was found to be out of specification for an impurity.

              2. Recalling Firm: Vintage Pharmaceuticals, LLC, Huntsville, AL, dba Qualitest Pharmaceuticals,                                                 Huntsville, AL by letters dated July 11 2011.

Manufacturers:  Time-Cap Laboratories Farmingdale, NY; Swiss Caps USA, Inc., Miami, FL Firm initiated recall is ongoing.

                   Products: 1) Bisacodyl delayed-release enteric coated tablets, USP, 5 mg, 100-count bottle, NDC 0603-                   2483-21, UPC 3 0603-2483-21 1. Recall # D-719-2011; Lot #: J071W, Exp 09/13;

                   2) Doc Q Lace (docusate sodium) softgels, 100 mg, 100-count bottle, NDC 0603-0145-21, UPC 3 0603-                   0145-217. Recall # D-720-2011;  2) Lot #: 103030, 103031, 103033, Exp 02/13; 103032, 104010,                                 104011, 104012, 104013, 104014, 105015, Exp 03/13; 105011, 105013, Exp 04/13                                               Reason:   Labeling:  Tablets/Capsule Imprinted with wrong I.D.: Incorrect product code printed on                    products.  

              3.  Recalling Firm: G & W Laboratories Inc., South Plainfield, NJ, by letters on April 21, 2011. Firm                       initiated recall is ongoing.

                  Product/Lot numbers:  G & W Bacitracin Ointment First Aid Antibiotic. Recall # D-713-2011;                           Lot # 028009009, Expiration Date July 2011; Lot # 028009006, Expiration Date May 2011

                  Reason:  Stability data does not support exp; failed 18-month stability test for microbiological assay. 

Jul 26     FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation.   FDA is taking this action as a result of two inspections of Cetero’s bioanalytical facility in Houston, Texas conducted in 2010, as well as the company’s own investigation and third party audit.  The inspections and audit identified significant instances of misconduct and violations of federal regulations, including falsification of documents and manipulation of samples.  The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame.  FDA concurs with the assessment of Cetero’s independent auditor who stated, “This misconduct appears to be significant enough to cast doubt on the data generated…If the foundation of the laboratory is corrupt, then the data generated will be also.”  As noted in a letter FDA sent to the company, Cetero also failed to conduct an adequate internal investigation to determine the extent and impact of the violations and failed to take sufficient measures to assure data integrity within the 5 year time frame.  As noted in the July 26 letter sent to Cetero, “FDA has reached this conclusion for three reasons: (1) the widespread falsification of dates and times in laboratory records for subject sample extractions, (2) the apparent manipulation of equilibration or ‘prep’ run samples to meet pre-determined acceptance criteria, and (3) lack of documentation regarding ‘prep’ runs that prevented you from conducting an adequate internal investigation to determine the extent and impact of these violations.”

Jul 26     Serious CNS Reactions Possible When Methylene Blue Is Given To Patients Taking Certain Psychiatric Medications.   On July 26, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of reports of serious central nervous system reactions when the drug methylene blue is given to patients taking serotonergic psychiatric medications. Methylene blue is commonly used in diagnostic procedures and is also used to treat a number of medical conditions.
Although the exact mechanism of this drug interaction is unknown, methylene blue inhibits the action of monoamine oxidase a—an enzyme responsible for breaking down serotonin in the brain. It is believed that when methylene blue is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome. Signs and symptoms include mental changes including confusion, hyperactivity, and memory problems; muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever.  Healthcare professionals and patients may not realize that methylene blue has MAOI properties. Methylene blue should generally not be given to patients taking serotonergic drugs. However, there are some conditions that may be life-threatening or require urgent treatment with methylene blue such as when it is used in the emergency treatment of:                                                                       

·         methemoglobinemia,

·         ifosfamide-induced encephalopathy, or

·         cyanide poisoning.

Safety information about these potential drug interactions and important drug usage recommendations for emergency and non-emergency situations are being added to the drug labels for serotonergic psychiatric medications.   More at:  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm266219.htm 

Jul 26     Zyvox (linezolid) Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications.   Linezolid should generally not be given to patients taking serotonergic drugs.  FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).  Linezolid is used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). It is a reversible monoamine oxidase inhibitor (MAOI). Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A — an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome — signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.

Jul 22     Enforcement Reports - Drug Recalls

1. Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on February 23, 2010..

Manufacturer: Teva Pharmaceutical Industries, Har Hozvim. Jerusalem, Israel. Firm initiated recall is ongoing..

                   Product:  Paroxetine Tablets USP, 20 mg, 90-count bottle, Rx only; NDC# 0093-7115-98. Recall # D-                   700-2011; Lot #: 07Y085

Reason:   CGMP Deviations: Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production"

               2. Recalling Firm: King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN, by letter on                    July 7, firm initiated recall is ongoing.

                   Product:  Levoxyl (levothyroxine sodium) Tablets, USP, 75 mcg, 1000-count bottle, Rx only; NDC                    60793-852- 10; UPC 3 60793 85210 2. Recall # D-704-2011; Lot #: 60809, Exp 03/31/12

                   Reason:   Adulterated Presence of Foreign Tablets: The firm received a complaint of a single 200 mcg                    Levoxyl Tablet co-mingled in a 1000-count bottle of Levoxyl Tablets, USP 75 mcg.

 

               3. Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on April 1, 2011 and on                      April 22, 2011.

                   Manufacturer:  Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.

                   Product:  Cyclobenzaprine Hydrochloride 10 mg Tablets USP, 1000-count bottle, Rx only; NDC 50111-        563-03; UPC 3 50111-563-03 2. Recall # D-706-2011; Lot #: 703327, Exp 01/12; 315316, Exp 02/12

                   Reason:  CGMP Deviations: Some tablets may not conform to weight specifications.

 

               4. Recalling Firm/Manufacturer:  Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ, by letters on June 16,                            2011 and press release on June 17, 2011. Firm initiated recall is ongoing.

                   Products:  1) Risperidone Tablets 2 mg, 60 count bottles, Rx only, NDC 50458-593-60. Recall # D-709-                   2011; Lot # 0LG175, EXP 08-12;

                   2)  Risperdal Tablets (Risperidone), 3 mg, 60 count bottles, Rx only, NDC 50458-330-06. Recall # D-                   710-2011; Lot # 0GG904, Exp 05-12

                   Reason:  Chemical contamination; TBA 

               5. Recalling Firm: American Health Packaging, Columbus, OH, by letter on March 18, 2011.
                   Manufacturer: Impax Laboratories, Hayward, CA. Firm initiated recall is ongoing.

                   Product: Lofibra, Fenofibrate Capsules (Micronized), 200 mg, 30 UD, Rx only. NDC 0115-0533-01.                    Recall # D-701-2011; Lot #104122, and the Expiration Date: 05/31/2012

                   Reason:  Short fill; low-fill weight capsule.

6. Recalling Firm: Purdue Products L.P., Stamford CT, by letters dated April 27, 2011.

                   Manufacturer: Catalent Pharma Solutions, LLC, Saint Petersburg, FL. Firm initiated recall is ongoing.

                   Product:  Colace (docusate sodium) Stool Softener Capsules 100 mg, 30 count bottle, OTC, NDC 67618-        101-30. Recall # D-702-2011; Lot #: 0J8151, Exp 06/13

                   Reason:  Superpotent (Single Ingredient Drug): Colace (docusate sodium) stool softener 100 mg capsules                  are being recalled due to an out of specification result for the active ingredient. 

7. Recalling Firm:   Magno Humphries Inc., Tigard, OR, by telephone on February 24, 2009.

                   Manufacturer:  Aaron Industries Inc., Lynwood, CA. Firm initiated recall is ongoing.

                 Product:   Bi Mart Tussin DM, Cough Suppressant/Expectorant, 8 fl oz (237 ml), Dextromethorphan                   HBr, USP 10 mg, Guaifenesin USP 100 mg. UPC code: 0 71357 00190 3, Product label # G920l-008-ll-2.          Same lot from supplier packaged under a different lot numbers. Recall # D-712-2011;  Lot codes: 338495             and 338531, Exp date 08/10

                   Reason:   Presence of Precipitate: Tussin DM was observed with fibrous crystalline substance or floating                    material.

Jul 21    FDA Drug Safety Communication:  Ongoing Safety Review of Oral Osteoporosis Drugs (bisphosphonates) and Potential Increased Risk of Esophageal Cancer.   Bisphosphonates include the following products: Fosamax (alendronate), Fosamax-D, Actonel (risedronate), Actonel + Ca, Boniva (ibandronate), Atelvia (risedronate delayed release), Didronel (etidronate), Reclast, Skelid (tiludronate), and Zometa.  One study found a doubling of the risk of esophageal cancer among patients who had 10 or more prescriptions of the drugs or who had taken the drugs over 3 years.  At this time the FDA believes the benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis outweighs the potential risks.  For more information go to:  http://www.fda.gov/Drugs/DrugSafety/ucm263320.htm

Jul 19    FDA Clinical Investigator Training Course.  The third annual FDA Clinical Investigator Training Course, co-sponsored by the Food and Drug Administration's (FDA) Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI), is now open for registration.  DATES:  November 7 and 8, from 8 a.m. to 5 p.m. and on November 9, from 8 a.m. to 3:00 p.m.  LOCATION:  National Labor College, 10000 New Hampshire Avenue, Silver Spring, MD 20903.  REGISTRATION: Registration ends October 28, 2011.   COST:  $400.  Please find additional information at: http://www.fda.gov/Drugs/NewsEvents/ucm261639.htm

Jul 19     FDA Proposes Health Smartphone Application Guidelines   The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended.  The proposed guidelines7 were posted on the Federal Register website Thursday.  Consumers may weigh-in on the guidelines during a public comment period that ends Oct. 19.  For more information, visit the FDA’s Mobile Medical Apps page:   http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm

Jul 16     Drug Shortages – Amphetamine Mixed Salts, ER Capsules.  Shire’s Adderal XR capsules and Teva’s generic are in short supply due to active pharmaceutical ingredient supply issues.  Product will be released as it becomes available.  

Jul 13     Enforcement Reports - Drug Recalls

1.  Recalling Firm:  UDL Laboratories, Inc., Rockford, IL, by letter on March 7, 2011, April 8, 2011 and on April 28, 2011.                                                                                                                                                Manufacturer:   Pliva Krakow S.A., Krakow, Poland. Firm initiated recall is ongoing.                   Product/lot number:       1. Hydralazine HCl Tablets, USP 10 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-074-20. Recall # D-616-2011;  Lot 0P643, expiration date 01/12; lot 9V346, expiration date 06/11; lot 0J293, expiration date 12/11;

2) Hydralazine HCl Tablets, USP 50 mg; packaged in cartons of 10 blister cards containing 10 tablets each (100 tablets), Rx only, NDC 51079-076-20. Recall # D-617-2011; Lot 0S788, expiration date 05/12          Reason:   Tablet Thickness: Some tablets may not conform to weight requirements/specifications.

2.      Recalling Firm/Manufac, turer: Safecor Health, LLC, Woburn MA, by letter on March 2, 2011.  Firm initiated recall ongoing.                                                                                                                                   Product:  1) RE-PB Hyos Elixir,  5 mL and 10 mL Oral Syringes                                                                        2) Donnatal Elixir, 5 mL and 10 mL Oral Syringes                                                                               3) Levetiracetam Oral Solution, 5, 10, and 20 mL Oral Syringes                                                         4) Methadone HCl Oral Solution, 3 mL and 10 mL Oral Syringes                                                       5) Keppra (levetiracetam) Oral Solution, 1 mL and 5 mL Oral Syringe                                                6) Methadone HCl Oral Solution, 5 mL Oral Syringe                                                                     Reason: Container Leakage: Drug product may not contain the labeled volume/dose due to evaporation or leakage                                                                                                                                                                                                     

3.  Recalling Firm: Multimex, Tucker, GA, by press release on May 9, 2011 and by letter on May 11, 2011.             Manufacturers:  Goper's International LLC, San Diego, CA;  Multimex, Tucker, GA. Firm initiated recall is ongoing.                                                                                                                             Product/lot number:  1) Sinalar Decongestant and Nostrils Lubricant, Dropper with 0.50 oz., UPC 619114001006. Recall # D-624-2011; Lot #SINNA 1209;                                                                           2) Sinalar Inflammation and Infection of Ear, Dropper with 0.5 fl. oz., UPC 619114010036. Recall # D-625-2011; Lot #SINOT02-11;                                                                                                                    3) Sinalar Inflammation and Eye Infection, Dropper with 0.5 fl. oz., UPC 619114010029.  Recall # D-626-2011; Lot #SINOF02-11

                     Reason:   The products are misbranded and unapproved new drugs.                                                                                                                                                                 

4.   Recalling Firm:  Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on May 31, 2011.           Manufacturer:  Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.      Product/lot number:  Lansoprazole Delayed-Release Capsules USP, 30 mg, 30-count capsules, Rx Only, NDC 0093-7351-56. Recall # D-629-2011; Lot #'s: 44L031, 44L032, Exp 01/12

      Reason: Discoloration: Some capsules may not meet the appearance specifications; Pellet color varies from white to pink (pellet color spec is off-white to beige).

5.      Recalling Firm/Manufacturer:  Safecor Health, LLC, Woburn, MA, by letter dated March 21, 2011. Firm initiated recall is ongoing.                                                                                                             Product/lot number:    Sixty-six different  “Split Tab” products                                                                   Reason:  Marketed without an approved NDA/ANDA: Split tabs distributed as an unapproved new drug.

               6.  Recalling Firm/Manufacturer:  Impax Laboratories, Inc., Hayward, CA, by letters on June 22, 2011.                     Firm initiated recall is ongoing.                                                                                                                                  Product/lot number:  Dantrolene Sodium Capsules, 25 mg, Rx only 100 count HDPE bottle Recall #D-              696-2011; Lot number: 000073105, Exp. date: 04/12 and Lot number: 000074634, Exp. date: 08/12

                     Reason:  Subpotent; empty capsules found in one lot of Dantrolene Sodium Capsules, 25 mg.

               7.  Recalling Firm:  Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by                     press release on June 24, 2011 and by letters on June 27, 2011.                                                                                Manufacturer:  Qualitest Pharmaceuticals, Charlotte, NC. Firm initiated recall is ongoing.                                   Product:  1) Hydrocodone Bitartrate and Acetaminophen Tablets, USP, C-III, 7.5 mg/500 mg, 1000-                    count, Rx only, May be habit forming. NDC 0603-3882-32. Recall # D-698-2011;

                    2) Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50 mg/325 mg/ 40 mg, 500-count, Rx Only,                          NDC 0603-2544-28. Recall # D-699-2011

                    Lot numbers:  1) and 2) Lot #s: C0390909A; C0400909A; C0410909A; C0590909B, Exp. 03/12                       Reason:  Labeling: Ingredient mix-up due to mislabeling; Butalbital, Acetaminophen, and Caffeine                     Tablets, USP 50 mg/325 mg/40 mg may be mislabeled as Hydrocodone Bitartrate/Acetaminophen, 7.5                         mg/500 mg Tablets.

Jul  8      “Slim Forte Slimming Capsule” and “Slim Forte Double Power Slimming Capsules” Contain Undeclared Drug Ingredient.  FDA laboratory analysis confirmed that “Slim Forte Slimming Capsules” and “Slim Forte Double Power Slimming Capsules” contain sibutramine.  Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons.  These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  These products may also interact in life threatening ways with other medications a consumer may be taking.

Jul  7      Guidance for Industry: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM259744.pdf

Jul  6      CDC Traveler’s Health: 2012 Yellow Book Now Available Online.  CDC Travelers’ Health is pleased to announce the online release of CDC Health Information for International Travel 2012 (widely known as the Yellow Book), the trusted travel medicine desktop reference for both health professionals and travelers. To view the online version of the Yellow Book or to order your own hard copy or e-book, visit the CDC Travelers’ Health website at www.cdc.gov/yellowbook .   The hard copy costs around $45.

Jul  5      FDA issues draft guidance on new dietary ingredients.  The purpose of this draft guidance is to clarify                agency expectations on new dietary ingredients for industry which is an important preventive control to                ensure that consumers are not exposed to unnecessary public health risks from new ingredients with                unknown safety profiles.  Dietary supplement manufacturers are required to notify the FDA in advance                when they intend to add a new dietary ingredient to their products, except in certain situations when the                ingredient has been part of the food supply and has not been chemically altered for use in supplements. The                notifications             must identify the new dietary ingredient and be accompanied by evidence on its safety. The      draft guidance is intended to inform and assist manufacturers, distributors, and others in deciding when a    premarket safety notification for a dietary supplement containing a new dietary ingredient is necessary and                in preparing premarket safety notifications.  It can be found at:                http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupple               ments/ucm257563.htm

Jun 29    CDER Statement on Avastin Hearing.  The public hearing on the Center for Drugs’ December 2010 proposal to withdraw approval of the metastatic breast cancer indication for Avastin is now complete. The Center and Genentech are scheduled to provide additional written submissions by July 28, 2011, and the docket will remain open for public comment until that date.   Following the closing of the docket, the Center for Drugs will await Commissioner Hamburg’s final decision on Avastin’s use for metastatic breast cancer. The Commissioner’s decision related to breast cancer will not affect Avastin’s approved indications for use in colon, lung, kidney, and brain cancers. That is, regardless of the final decision on metastatic breast cancer approval, Avastin will remain on the market.

Jun 28    Guidance for Industry – Q11 Development and Manufacture of Drug Substances.  This guidance can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM261078.pdf

Jun 28    McNeil Consumer Healthcare Announces Voluntary Recall of One Product Lot of Tylenol Extra Strength Caplets, 225 Count, Distributed in the U.S.   The recalled product (lot number ABA619) was manufactured in February, 2009.  McNeil is taking this action following a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).  This voluntary action is being taken as a precaution and the risk of serious adverse medical events is remote. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.  Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com1 or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Jun 27   Recall:  Endocet (Oxycodone/Acetaminophen) Tablets, (10 mg/325 mg).  Endo Pharmaceuticals  and FDA notified pharmacists and patients of a nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, (10 mg/325 mg) because some bottles may contain different strength tablets, resulting in  patients taking more than the intended acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content may result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.  The affected lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL and TN. These wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle.  Consumers who have the affected product should stop using the product and contact Endo’s agent Stericycle at 1-866-723-2681 for return of the product.

Jun 27   Recall:  Butalbital, Acetaminophen, and Caffeine Tablets (USP 50 mg, 325 mg, 40 mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5 mg, 500 mg).  Qualitest and FDA is notifying pharmacists and patients of a recall to the retail level of specific lots of Butalbital, Acetaminophen, and Caffeine Tablets and Hydrocodone Bitartrate and Acetaminophen Tablets due to possibility that the recalled bottles may contain incorrect tablets, and patients may unintentionally take butalbital and caffeine instead of hydrocodone. Unintentional administration of butalbital could result in symptoms such as sedation, lightheadedness, dizziness, and nausea. Additionally, patients with an allergy to butalbital could experience a hypersensitivity reaction.                                                                                                                           Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B                                                     Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B                                                                 These lots were distributed between November 13, 2009 and April 9, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Jun 27    New Guidance for Comment Only – Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h) of the Food and Drug Act.  This guidance is available for download at:  http://www.fda.gov/RegulatoryInformation/Guidances/ucm259059.htm

Jun 24    Resolved Drug Shortage – Thyroid (desiccated) Tablets.  Forest RLC announced that approved levothyroxine products are now available from multiple manufacturers.

May 27  Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.  Download at:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf

May 27  Determination of System Attributes for the Tracking and Tracing of Prescription Drugs; Reopening of the Comment Period.  FDA is reopening the comment period for the notice of public workshop published in the Federal Register of January 7, 2011 (76 FR 1182). In that notice, FDA announced a public workshop that took place on February 15 and 16, 2011, and requested public comment regarding the topics discussed at the workshop on determining system attributes for tracking and tracing prescription drugs. The workshop provided a forum for discussing possible approaches to developing a track-and-trace system and for obtaining input from supply chain partners on potential attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages. FDA is reopening the comment period to allow additional time for interested persons both to consider all the information provided by the Agency related to the workshop and to submit additional comments. Submit either electronic or written comments by June 22, 2011. Additional information is provided in the Federal Register Notice at:  http://www.gpo.gov/fdsys/pkg/FR-2011-05-23/pdf/2011-12617.pdf

May 25  FDA Warns Not To Feed SimplyThick to Premature Infants.  The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.  FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 17 cases of NEC, including five deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.  FDA is actively investigating the link between SimplyThick and these illnesses and deaths. FDA will provide updates as information is made available.

May 24           FDA/DDMAC sends letter to Dr. Tanveer Ahmad at Noven Pharmaceuticals concerning Pexeva Tablets.    In it, DDMAC requests that Noven immediately cease the dissemination of violative promotional materials for Pexeva.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM256863.pdf

May 13  FDA Requests Input on Development of User Fee Program for Biosimilar and Interchangeable Biological Products.  Biological products are produced in a living system such as a microorganism, plant, or animal cell, while small molecule drugs are typically made through chemical synthesis.   For more information, including the Federal Register notice:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215031.htm

May 13  Guidance for Industry on theSubmission of Summary Bioequivalence Data for Abbreviated New Drug Applications.   This guidance document is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods.  The guidance provides information on the following subjects:   Types of ANDA submissions covered by the regulations on BE studies;  Recommended format for summary reports of BE studies; and Types of formulations the Agency considers to be the same drug product formulation for different dosage forms based on differences in composition.  Federal Register Notice: http://www.gpo.gov/fdsys/pkg/FR-2011-05-06/pdf/2011-11102.pdf

May 13  Guidance – Exception From Informed Consent For Emergency Research.  This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR).  This guidance finalizes the draft guidance entitled, "Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research," dated July 2006 (published on August 29, 2006).  Guidance document:   http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM249673.pdf

May 11  Recall – Metformin Hydrochloride Tablets, 500 mg.  Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 23, 2011.  Lot # 35201115A, Exp 10/11.  Manufacturer: Novopharm Ltd., Scarborough Ontario, Canada. Firm initiated recall is ongoing.  Reason:  Failed Tablet Hardness: Some tablets may not meet friability specification.

May 10   Multi-Mex Distributor Inc. Recalls Dietary Supplements That May be Labeled as Antibiotic Drugs.

               The recall was initiated after an FDA inspection revealed the product packaging mimics antibiotics readily available in Mexico and possibly familiar to Hispanic consumers.  Warnings of these dietary supplements made news in Texas on Thursday, April 28th, when four children were taken to a Medical Center due to worsening illnesses after being given dietary supplements the parents may have believed were antibiotics and which were packaged to resemble antibiotics that are readily available as over the counter drugs in Mexico. Giving the dietary supplement delayed legitimate medical treatment. Although the labels were printed in English and Spanish, the packaging appears to be an intentional marketing ploy to mimic antibiotics and directed at Hispanic buyers. It was determined the children had been given a dietary supplement, Amoxilina, which the parents may have believed was the antibiotic Amoxicillin.

May 9    FDA/DDMAC sends letter to Ms. Katie Cairati at ChemGenex Pharmaceuticals concerning Omapro for Injection.   In it, DDMAC requests that ChemGenex immediately cease the dissemination of violative promotional materials for Omapro.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM254614.pdf

May 9    FDA/DDMAC sends letter to Mr. Brian Deutsch at Warner Chilcott, LLC concerning Atelvia for Injection.  In it, DDMAC requests that Warner Chilcott immediately cease the dissemination of violative promotional materials for Atelvia.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM254562.pdf

May 3    FDA/DDMAC sends letter to Mr. John Driscoll at Forest Laboratories, Inc., concerning Savella Tablets.  In it, DDMAC requests that Forest Labs immediately cease the dissemination of violative promotional materials for Savella.  This correspondence is available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM253625.pdf

.May 2   Bristol-Myers Squibb Initiates a Nationwide Recall of Coumadin (Warfarin Sodium) Crystalline     5 mg Tablets, Lot Number 9H49374A.  Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin® (warfarin sodium) Crystalline 5 mg tablets. Bottles of 1,000 tablets are distributed to pharmacies for further dispensing to patients in prescription quantities. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. The recall is a precautionary measure based on the company’s testing of tablets from a returned bottle. A single tablet was found to be higher in potency than expected.

May 2    FDA Approves New Treatment for Type 2 Diabetes.  The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.  People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.  Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.  Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.  Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

Apr 29   Ethos Environmental, Inc. Issues a Voluntary Recall of Specific Lots Of The Dietary Supplement Regenerect.  Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.  According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Apr 28   FDA approves Zytiga for late-stage prostate cancer.  The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).  In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.  Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.  The application was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Zytiga is being approved ahead of the product’s June 20, 2011 regulatory goal date.  The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.  Zytiga is marketed by Horsham, Pa.-based Centocor Ortho Biotech, Inc.

Apr 22   FDA/DDMAC sends letter to Kimberly A. Davis at Inspire Pharmaceuticals, Inc., concerning AzaSite (azithromycin ophthalmic Solution 1%)    In it, DDMAC requests that Inspire immediately cease the dissemination of violative promotional materials for AzaSite.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM252369.pdf

Apr 22            FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers.  The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.  Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of

May 2    FDA Approves New Treatment for Type 2 Diabetes.  The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.  People with Type 2 diabetes do not produce or respond normally to insulin, a hormone that regulates the amount of glucose in the blood. Over time, high blood glucose levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.  Type 2 diabetes is the most common form of the disease, affecting between 90 percent and 95 percent of the 24 million people in the United States with diabetes. Tradjenta increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or DPP-4, which leads to better blood glucose control.  Tradjenta was demonstrated to be safe and effective in eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with Type 2 diabetes. The studies showed improvement in blood glucose control compared with placebo.  Tradjenta has been studied as a stand-alone therapy and in combination with other Type 2 diabetes therapies including metformin, glimepiride, and pioglitazone. Tradjenta has not been studied in combination with insulin, and should not be used to treat people with Type 1 diabetes or in those who have increased ketones in their blood or urine (diabetic ketoacidosis). Tradjenta will be dispensed with an FDA-approved Patient Package Insert that explains the drug’s uses and risks. The most common side effects of Tradjenta are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain, and headache.  Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.

Apr 29   Ethos Environmental, Inc. Issues a Voluntary Recall of Specific Lots Of The Dietary Supplement Regenerect.  Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.  According to the FDA, use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA has advised that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Apr 28   FDA approves Zytiga for late-stage prostate cancer.  The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).  In prostate cancer, the male sex hormone testosterone stimulates prostate tumors to grow. Drugs or surgery are used to reduce testosterone production or to block testosterone’s effects. However, sometimes prostate cancer can continue to grow even when testosterone levels are low. Men with these cancers are said to have castration-resistant prostate cancer.  Zytiga is a pill that targets a protein called cytochrome P450 17A1 (CYP17A1) which plays an important role in the production of testosterone. The drug works by decreasing the production of this hormone that would stimulate cancer cells to continue growing.  The application was reviewed under the FDA’s priority review program, which provides for an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists. Zytiga is being approved ahead of the product’s June 20, 2011 regulatory goal date.  The most commonly reported side effects in patients receiving Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention (usually of the legs and feet), muscle discomfort, hot flashes, diarrhea, urinary tract infection, cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion and upper respiratory tract infection.  Zytiga is marketed by Horsham, Pa.-based Centocor Ortho Biotech, Inc.

 Apr 22  FDA/DDMAC sends letter to Kimberly A. Davis at Inspire Pharmaceuticals, Inc., concerning AzaSite (azithromycin ophthalmic Solution 1%)    In it, DDMAC requests that Inspire immediately cease the dissemination of violative promotional materials for AzaSite.  This correspondence is available at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM252369.pdf

Apr 22            FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers.  The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.  Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of

  Mar 2     FDA Prompts Removal of Unapproved Drugs From Market.  The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.  This is the final step in a long battle to force these products off the market that started in the mid-1980s.  The FDA’s actions accelerated with their Unapproved Drugs Initiative which began in June 2006.  The initiative is the agency’s risk-based enforcement approach to efficiently and rationally bring all unapproved new drugs into the approval process.  One of the goals of the initiative is to reduce consumer exposure to drugs that are not proven safe, effective, and of high quality.  Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the FDA for safety, effectiveness, and quality. People may be at greater risk when using these products than when using FDA-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC). Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.  In addition, the Federal Register Notice specifically addressed extended release products, tannates, and immediate release products.  More information can be found at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245048.htm                            A complete list of non-narcotic drugs effected can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm245106.htm                                                             A list of enforcement actions by drug class can be found at:  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm238675.htm  

 Mar 1     Draft Guidance: "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)"    FDA has issued a draft guidance for industry entitled "Medication Guides--Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)." This draft guidance addresses two topics pertaining to Medication Guides for drug and biological products. First, the draft guidance addresses when FDA intends to exercise enforcement discretion regarding dispensing requirements for Medication Guides that must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient for self-administration or to the patient's caregiver for administration to the patient. Second, the draft guidance addresses when a Medication Guide will be required as part of a REMS. The draft guidance is intended to answer questions that have arisen concerning these topics. This guidance document is located at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM244570.pdf

 Mar 1     OOPD/ORDR Course: "The Science of Small Clinical Trials"    FDA Office of Orphan Products Development (OOPD) and NIH's Office of Rare Disease Research (ORDR) are pleased to announce that registration is now open for their popular live/online course, "The Science of Small Clinical Trials," which will be offered at FDA's White Oak campus between April 19 and May 12 2011. Open to any interested person, this 8-lecture series can be attended in person or via the Internet, and will be presented by outstanding speakers from within and outside FDA/NIH.

This course deals with issues arising in the design and analysis of clinical trials based on small study populations. While small clinical trials are a necessity in the context of rare diseases, being able to conduct small trials with scientific rigor is of increasing importance in other contexts, particularly as genomic science begins to provide opportunities for individualized pharmacology. This course provides a broad overview of its subject, and does not require a strong mathematical background. It is not a high-level statistical seminar. Nor is it an introductory statistics course, assuming no prior knowledge whatsoever. The target audience is professionals with some awareness of basic statistical concepts who are interested in drug/device evaluation and regulatory affairs, in the context of small study populations (as for rare diseases, or personalized medicine).

You may find more information about the course at:   http://small-trials.keenminds.org/           

 Feb 25    E&J Brandy Announces A Nationwide Recall Of Stainless Steel Flasks Due To Possible Lead Risk   E&J Brandy announces the following voluntary recall. Consumers should immediately stop using the stainless steel flask sold in E&J® VSOP gift sets in 2006, 2007, 2008, 2009 and 2010 and in E&J® XO gift sets sold in 2006.  This voluntary recall pertains only to stainless steel flasks manufactured for E&J Brandy because laboratory results revealed that brandy stored in the flask under certain conditions may show elevated levels of lead.  Prolonged exposure to elevated levels of lead may have negative health effects.  This recall does not pertain to any bottles of E&J Brandy.
The affected flasks included in the 2006, 2007, 2008, 2009 and 2010 E&J® VSOP gift sets are silver, rectangular in shape and have “E&J VSOP” etched on the front.  The affected flasks included in the 2006 E&J® XO gift sets are silver and round in shape with “E&J” etched on the front.  These gift sets were sold throughout the United States through a variety of retail stores as recently as this past holiday season.  Some flasks in leather cases were also given away as a promotional item in 2007.
Consumers in possession of an affected stainless steel flask should call the consumer recall hotline at 1-866-959-8477 at any time for instructions on how to return the product and receive a full refund. The brandy contained in the gift set is unaffected and may be safely consumed but any brandy or other liquid in the flask should not be consumed. 

Feb 28    HHS Awards Contracts Totaling $215 Million to Develop New Flu Vaccine Technology   The U.S. Department of Health and Human Services (HHS) awarded two contracts today to help make vaccine available more quickly for seasonal flu outbreaks and pandemics. The contracts for advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine total $215 million  HHS awarded one contract to Novavax, Inc., of Rockville, Md., for $97 million over the first three years, which can be extended for an additional two years, for a total contract value of $179.1 million. HHS awarded a separate contract to VaxInnate, Inc. of Cranbury, N.J., for $117.9 million over the first three years, which can be extended for two additional years, for a total contract value of $196.6 million.  Under its contract, Novavax is to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.  VaxInnate is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.

Feb 22    Biotab Nutraceuticals, Inc. Issues Voluntary Recall of Specific Lots of the Nutritional Supplement Extenze (Men’s Regular) Due to Counterfeiting Biotab Nutraceuticals, Inc. (“Biotab”) is conducting a voluntary recall of two lots of EXTENZE nutritional supplement tablets. Some packages bearing lot numbers 0709241 and 0509075 are counterfeit products containing undeclared drug ingredients that can pose a serious risk to health.  Biotab learned about the problem after being notified by the Food and Drug Administration (FDA) that two lots of counterfeit product purporting to be EXTENZE contain undeclared drug ingredients. More specifically, lot 0709241 contains tadalafil and sildenafil, and lot 0509075 contains tadalafil and sibutramine. The counterfeit products are sold at retail nationwide in the form of carded four-packs (lot 0709241) and in the form of a box of thirty tablets divided into two fifteen tablet blister packs (lot 0509075).  Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED). These drugs may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek Extenze to enhance sexual performance.  Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.  The counterfeit Extenze product is not manufactured, distributed or packaged by Biotab, but is falsely marked with the same lot numbers used by Biotab for its genuine product. Because it is very difficult to distinguish the counterfeit from the genuine product, Biotab decided to conduct this voluntary recall of the two affected lots. It is possible that there may be other counterfeit products on the market that have yet to be identified.  Consumers in possession of product from the lots in question only should return any unused product to its immediate supplier for a direct refund. Customers with questions can call (626) 775-6334 Monday through Friday between 9 a.m. and 4 p.m. for further instructions or information with respect to the return and refund process. Additionally, Biotab will refund the supplier for any genuine (non-counterfeit) product returned to it.

Feb 18    Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall.  Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily expanding its previously announced recall of Jantoven® Warfarin Sodium, USP, 3 mg Tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating the recall as a precautionary measure after a bottle labeled as Jantoven® Warfarin Sodium, USP, 3 mg Tablets was found by a retail pharmacy to contain tablets at a higher, 10 mg strength.  The expanded recall includes the following products:  Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin.  More information at:  http://www.fda.gov/Safety/Recalls/ucm244111.htm

Feb 17    Guidance for Industry:  Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.   It can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243702.pdf 

Feb 16    Guidance for Industry:  Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets.  This guidance can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM243537.pdf

Feb 16    Seizure:  U.S. Marshals Seize Unapproved Drug (Auralgan Otic Solution).  U.S. Marshals, at the request of the U.S. Food and Drug Administration yesterday, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky.  Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS.  Deston’s sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.  The value of the products seized is estimated to be $16.5 million.  On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs.  The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act.  Today’s action is part of the FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

Feb 15    HHS Announces $750 Million Investment in Prevention.   HHS announced a $750 million investment in prevention and public health, funded through the Prevention and Public Health Fund created by the new health care law. Building on $500 million in investments last year, these new dollars will help prevent tobacco use, obesity, heart disease, stroke, and cancer; increase immunizations; and empower individuals and communities with tools and resources for local prevention and health initiatives.

Feb 15   BARDA Supports Development of Drugs to Treat Radiation Injuries.  Two contracts for advanced development of drugs to treat skin and lung injuries associated with acute radiation syndrome (ARS) were awarded this week by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). These contracts are the first by BARDA to address the skin and lung injuries that arise from acute exposure to high levels of ionizing radiation – the type of radiation that results from a nuclear blast.  The contracts were awarded to Aeolus Pharmaceuticals Inc., of Mission Viejo, Calif., and U.S. Biotest Inc., of San Luis Obispo, Calif., and support research studies and manufacturing efforts by each company in developing their respective drugs.   The Aeolus contract is valued at $10.4 million for the first year and can be extended for a total of five years and up to a total of $118.4 million. Aeolus is developing a broad-spectrum antioxidant drug known as AEOL 10150. This drug was designed originally to reduce the damage caused by radiation during cancer treatments. For BARDA, the drug will be developed for use in treating lung injuries associated with acute radiation syndrome, known as pulmonary acute radiation syndrome or lung-ARS.  The U.S. Biotest contract is valued at $4.5 million for the first 16 months and could be extended for a total of five years and up to a total of $14 million. The contract with U.S. Biotest supports advanced development of DSC127, a drug applied to the skin to help body tissue heal after being exposed to ionizing radiation.   These contracts are part of the HHS radiological and nuclear threats preparedness strategy.

Feb 9      Recalls           Drugs – Class II                                                                                                                           1. Armour Thyroid (Thyroid Tablets, USP) ½ grain.                                                                Recalling Firm: Forest Pharmaceuticals.                                                                                                                     Numerous Lots                                                                                                                                        Reason:  Labeling: Label error on declared strength; some bottles are mislabeled as containing 1/2-grain tablets but actually contain 1-grain tablets. The entire lot is being recalled even though some bottles are labeled correctly because bottles of 1/2-grain and 1-grain could be shrink-wrapped together.

               Recalls           Drugs – Class III                                                                                                                   1. Lorazepam Tablets, USP, 0.5 mg, 1 mg, and 2mg.                                                                             Recalling Firm:  McKesson Packaging Services; Manufacturer Sandoz, Inc.                                   Numerous lots are recalled                                                                                                                                      Reason:  Impurities/Degrad, ation Products:  The product may not meet the specification for impurity levels throughout the assigned shelf life.                                                                                                                                                                                                                                                                             2.  Acyclovir Tablets 2 800 mg and Capsules 200 mg                                                                         Recalling Firm:  Teva Pharmaceuticals USA, Inc.                                                                                       200 mg: Lot # 35315261A, 35315263A, Exp 04/12;
800 mg: Lot # 35315369A, Exp 04/12                                                                                                   Reason: Presence of Foreign Substance: Presence of food grade gasket material may be present in the product.

               For more information go to: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm242808.htm                                                      

Feb 9      New Draft Guidance:  Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography (PET) Drug Products.  This draft guidance is intended to assist manufacturers of certain PET drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations.  The revised guidance is being issued again as a draft for comment because FDA’s perspective has changed significantly since issuance of the March 2000 draft guidance.  Guidance document can be downloaded at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078738.pdf

Feb 7      Recall – Incorrect Package Labeling:  1. Hydrocodone Bitartrate and Acetaminophen Tablets.                 2. Phenobarbital Tablets by Qualitest.   ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.                           As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naïve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.  The recall includes the following products:                                                                                                                                   Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A                                                                          Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A                                                                                                                  Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).                                                                                          RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement.  Lot numbers can be found on the side of the bottle.

Feb 4      Recall – Contamination:  Triad Alcohol Prep Product   Watson Pharmaceuticals, Inc. (NYSE: WPI), announced today the market recall of alcohol prep pads manufactured by Triad Group which is a component of a convenience kit that is distributed with its products. Triad Group is recalling the alcohol prep pads packaged with products, including Watson’s Trelstar® (triptorelin pamoate for injectable suspension) product, due to potential contamination of the pads with the bacteria, Bacillus cereus, which could result in life threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.   

Feb 4      Recall – Undeclared Drug Ingredient:  Celerite Slimming Capsules.  Southampton, PA, Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contains an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement product Celerite™ Slimming Capsules are being recalled.  You can learn more at:  http://www.fda.gov/Safety/Recalls/ucm242199.htm

 Feb 4      FDA Approved Gardasil to Prevent Anal Cancer.   The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.  Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.  Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.  Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well.  More at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237941.htm

Feb 2      Drug Shortages – Discontinued Product:  Mebaral (mephobarbital 32 mg, 50 mg, and 100 mg tablets).   Lundbeck Inc. is no longer able to manufacture Mebaral CIV (brand of mephobarbital tablets, USP), and the company anticipates its limited remaining supply to be depleted by year end 2011. Once the current stock of Mebaral is depleted, Lundbeck will no longer be making product available. Due to the limited remaining Mebaral supply, we encourage patients to work with their physician to transition to alternative therapies rather than starting a new course of therapy with Mebaral.

Feb 1      FDA Has Published a PDUFA IV Information Technology Assessment for Fiscal Year 2010.

               You can download a copy from: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM241656.pdf

 Feb 1      The NDC Database file is updated Semimonthly.   It is available at:  http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm

Jan 31    USDA and HHS Announce New Dietary Guidelines to Help Americans Make Healthier Food Choices and Confront Obesity Epidemic.  “The 2010 Dietary Guidelines are being released at a time when the majority of adults and one in three children is overweight or obese and this is a crisis that we can no longer ignore,” said Agriculture Secretary Tom Vilsack.  “These new and improved dietary recommendations give individuals the information to make thoughtful choices of healthier foods in the right portions and to complement those choices with physical activity.  The bottom line is that most Americans need to trim our waistlines to reduce the risk of developing diet-related chronic disease. Improving our eating habits is not on, ly good for every individual and family, but also for our country.”                   The new 2010 Dietary Guidelines for Americans focus on balancing calories with physical activity, and encourage Americans to consume more healthy foods like vegetables, fruits, whole grains, fat-free and low-fat dairy products, and seafood, and to consume less sodium, saturated and trans fats, added sugars, and refined grains.                                                                                                                                      More consumer-friendly advice and tools, including a next generation Food Pyramid, will be released by USDA and HHS in the coming months. Below is a preview of some of the tips that will be provided to help consumers translate the Dietary Guidelines into their everyday lives:                                            

·               Enjoy your food, but eat less.

·               Avoid oversized portions.

·               Make half your plate fruits and vegetables.

·               Switch to fat-free or low-fat (1%) milk.   

·               Compare sodium in foods like soup, bread, and frozen meals – choose foods with lower numbers.

·               Drink water instead of sugary drinks.                                                                                                    

More information at http://www.hhs.gov/news/press/2011pres/01/20110131a.html

Jan 27    Fourth FDA Orphan Drug Designation Workshop Scheduled for Feb 28 – March 1, 2011  The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.  Orphan drugs are either drugs or biologics intended for the treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing the drug. Orphan designation qualifies the applicant to receive certain benefits, such as tax credits and marketing incentives, from the federal government in exchange for developing the drug.                                                                                                     During the workshop, participants will propose a specific drug for a specific rare disease and work on an orphan designation application to submit to the FDA at the conclusion of the workshop. FDA staff will provide one-on-one guidance to help participants develop strong applications. Designation requires there be a scientific rationale for expecting the proposed drug to be effective in the treatment, prevention, or diagnosis of that disease or condition.  More information can be found at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm241230.htm

Jan 25    FDA has announced a revision to the Guidance for Industry:  Process Validation: General Principles and Practices (PDF 293 KB).  It can be downloaded from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf

Jan 24    HHS releases $200 Million in Emergency Funding for States for Energy Assistance   .  The money is intended for use helping eligible low income homeowners and renters meet home energy costs.  For a complete listing of state allocations of funds released today go to: http://www.acf.hhs.gov/news/press/2011/fy11_liheap_funds.html.      

Jan 19    CDER Has Published a Guidance Agenda for 2011.  You can download it at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079647.pdf

Jan 19    FDA to Improve Most Common Review Path for Medical Devices.   The U.S. Food and Drug Administration today unveiled a plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices.   Key actions include:

·               Streamlining the “de novo” review process for certain innovative, lower-risk medical devices,

·               Clarifying when clinical data should be submitted in a premarket submission, guidance that will    increase the efficiency and transparency of the review process,

·               Establishing a new Center Science Council of senior FDA experts to assure timely and consistent          science-based decision making.

These actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH).      Before marketing most lower-risk medical products such as certain catheters or diagnostic imaging devices, manufacturers must provide the FDA with a premarket notification submission.   These submissions are known as 510(k)s for the section of the Federal Food, Drug, and Cosmetic Act that describes this notification requirement. Generally, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk.  Read more at:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm

Jan 18    New Guidance for Industry:   Size of Beads in Drug Products Labeled for Sprinkle (PDF – 44KB).  It can be downloaded at:  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM240243           

Jan 18   FDA Announces a PQRI Workshop:  Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP), February 22-23 2011, Hyatt Regency Bethesda.  Meeting information can be found at: http://www.pqri.org/pdfs/PODP_Workshop_final_02-11.pdf       

Jan 18   FDA is Announcing a Public Workshop entitled, “Determination of System Attributes for the Tracking and Tracing of Drugs”.  This public workshop is intended to provide a forum for discussing potential approaches toward a track and trace system and obtaining input from supply chain partners on attributes and standards for the identification, authentication, and tracking and tracing of prescription drug packages, and to further the Agency’s goal of protecting public health by securing the drug supply chain against the introduction of counterfeit and other substandard drugs.  The public workshop will be held on February 15 and 16, 2011.  Please find additional information about this workshop at: http://edocket.access.gpo.gov/2011/pdf/2011-72.pdf

Jan 18    A Draft Guidance for Industry is Being Circulated for comments on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.  This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008. To ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by March 8, 2011.  Please find additional information about this draft guidance at:   http://edocket.access.gpo.gov/2011/pdf/2011-94.pdf    

Jan 18    Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations.  This draft guidance document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It also describes FDA’s recommended procedures for ensuring the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection. To ensure that FDA considers your comments on the draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by April 7, 2011.  Please find additional information about this draft guidance at: http://edocket.access.gpo.gov/2011/pdf/2011-73.pdf 

Jan 18   The FDA Data Standards Council Announced the 2011 Structured Product Labeling (SPL) Training Session Schedule.  The new schedule can be found at:  http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm155705.htm

 Jan 18    The Federal Government Obtained Permanent Injunction Against Deltex Pharmaceuticals, Inc.  The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan. The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.  Deltex is a contract manufacturer and distributor of prescription and over-the-counter (OTC) drug products.  Deltex failed to obtain required FDA approval for its prescription drug products, failed to comply with FDA regulations governing OTC drug products, and failed to comply with current good manufacturing practice (cGMP) requirements.  The consent decree also subjects the defendants to penalties of $2,500 per day if they fail to comply with any of the provisions of the consent decree, and an additional $500 for each violation.

 Jan 18   McNeil Consumer Healthcare Initiates Voluntary Recall of Certain OTC Products.  In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is voluntarily recalling, at the wholesale level, certain lots of TYLENOL® 8 Hour, TYLENOL® Arthritis Pain, ROLAIDS and TYLENOL® upper respiratory products, and certain lots of BENADRYL®, SUDAFED PE®, and SINUTAB® products distributed in the United States, the Caribbean, and Brazil. These products were manufactured at the McNeil plant in Fort Washington, PA prior to April 2010, when production at the facility was suspended.  Consumers can access full product details and other information about the recall on the www.mcneilproductrecall.com website or by calling our Consumer Care Center at 1-888-222-6036 (available Monday-Friday from 8 a.m. – 8 p.m. ET and Saturday – Sunday, 9 a.m. – 5 p.m. Eastern Time).

Jan 12   Recalls

               1.  PRODUCT - LISINOPRIL
Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx only; NDC 0172-3758-80. Recall # D-157-2011
CODE
Lot # TE03074, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated November 3, 2010.
Manufacturer: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India. Firm initiated recall is ongoing.
REASON
CGMP Deviations: some of the white tablets exhibit a blue discoloration.

               2.  PRODUCT - LIPITOR
Lipitor (atorvastatin calcium) tablets, 40 mg, 90 count bottle, Rx only, NDC 0071-0157-23. Recall # D-161-2011  
CODE
Lot # 0836050, Exp 04/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letter and press release on December 17, 2010.
Manufacturers: Pfizer Ireland Pharmaceuticals, Cork, Ireland;
Pfizer Manufacturing Deutschland Gmbh, Freiburg, Germany;
Rexam, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.       3.  PRODUCT – METOPROLOL TARTRATE
1) Metoprolol Tartrate Tablets, USP, 50 mg, a) 100 count bottles (NDC 0781-1223-01), b) 1000 count bottles (NDC 0781-1223-10), Rx only. Recall # D-162-2011;                                                                      2) Metoprolol Tartrate Tablets, USP, 100 mg, a) 100 count bottle (NDC 0781-1228-01), b) 1000 count bottles (NDC 0781-1228-10), Rx only. Recall # D-163-2011
CODE  Too numerous to list
RECALLING FIRM/MANUFACTURER
Sandoz Inc., Broomfield, CO, by letters on November 18, 2010 and January 5, 2011. Firm initiated recall is ongoing.
REASON
Failed USP Content Uniformity Requirements: Metoprolol batches may exhibit non-homogenous granulation.

               4.  PRODUCT - EQUALINE BRAND OF RANITIDINE
Equaline Maximum Strength Heartburn Relief Ranitidine tablets USP 150 mg acid reducer, OTC, 1) 50 tablets (doses), NDC 41163-404-50, 2) 65 tablets (65 doses), NDC 41163-404-61. Recall # D-156-2011
CODE
Lot number: 7945253B, Exp 07/12; 7945253C, Exp 07/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy's Laboratories Inc., Bridgewater, NJ, by letter on November 15, 2010.   
Manufacturer: Dr. Reddy's Laboratories Louisiana LLC. Shreveport, LA. Firm initiated recall is ongoing.
REASON
Label Error on Declared Strength: Ranitidine tablets carton states 'Compare to Zantac 75' whereas it should state "Compare to Zantac 150'.  

 5.      PRODUCT -  SE-NATAL 19, SE-NATAL 90, AND SETON ET-EC
Se-Natal 19 Chewable Tablets; Vitamins and Minerals with Folic Acid; 100 tablets; Rx only; NDC #13925-01-1701. Recall # Recall # D-158-2011;                                                                                                2) Seton ET-EC Tablets, NDC # 13925-10-1060; this product is package in bulk containers. Firm states they do not have a label available for this product since it is in bulk. It is a Prenatal Multivitamin and Minerals with Iron and Folic Acid. Recall # D-159-2011;                                                                                 3) Se-Natal 90 Prenatal Multivitamin/Mineral Tablets; 100 tablets; Rx only; NDC # 13925-102-01. Recall # D-160-2011
CODE
1) Lot # 906020, Exp 04/11;
2) Lot # 903021, Exp 04/11;
3) Lot # 904083, Exp 04/11
RECALLING FIRM/MANUFACTURER
Rasi Laboratories, Inc., Somerset, NJ, by letters on September 23, 2010 and October 21, 2010. Firm initiated recall is ongoing.
REASON
Superpotent Multiple Ingredient Drug: Prescription prenatal vitamins do not meet the product specifications for iron due to its high content and ascorbic acid due to its low content.

Jan 13   The Latest Cumulative Supplement of the Orange Book is Available.  You can download at:   http://www.fda.gov/downloads/Drugs/InformationOnDrugs/UCM086233.pdf

Jan 13    FDA Limits Acetaminophen in Prescription Combination Products: Requires Liver Toxicity Warnings.   The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule. The FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products to warn of the potential risk for severe liver injury.

Jan 12    Public Notification:  “Celerite Slimming Capsules” Contains Undeclared Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Celerite Slimming Capsules,” a product for weight loss sold on various websites, such as www.celeriteweightloss.com.  Claims made for the product falsely state that it is “safe” and an “all-natural herbal weight loss remedy.”  FDA laboratory analysis confirmed that “Celerite Slimming Capsules” contain sibutramine. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.  This product may also interact in life threatening ways with other medications a consumer may be taking.  This notification is to inform the public of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

 Jan 12     Legionnaires’ Disease in Cozumel, Mexico.  An outbreak of Legionnaires’ disease is ongoing at the Regency Club Vacation Resort and Wyndham Cozumel Resort & Spa (formerly Reef Club Cozumel), a hotel complex, on the island of Cozumel, Mexico. Since May 2008, there have been a total of nine confirmed cases of Legionnaires’ disease among tourists from the United States and the Netherlands who have stayed at this resort.  Based on findings from a public health investigation in April 2010, disinfection of the resort’s shared potable water system was recommended. Although measures were taken at the resort to disinfect the water system, in December 2010, CDC was notified of the ninth case associated with the resort, suggesting that there is an ongoing source of exposure.  Symptoms begin 2–14 days after exposure and include high fever, cough, and shortness of breath. Many people also have diarrhea, headaches, or muscle aches. Legionnaires’ disease can be a severe and fatal illness but most persons will recover with appropriate antibiotic treatment.

 Jan 11    Update from CDER, FDA/CMS Meeting last December, Janet Woodcock, M.D.   The slides from her presentation may be viewed at:  http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM239634.pdf

Jan 10   FDA Approves Opioid Analgesic to Help Cancer Patients Manage Pain.  The U.S. Food and Drug Administration approved Abstral (fentanyl) transmucosal tablets to manage breakthrough pain for adults with cancer.  Fentanyl immediate-release transmucosal medications are administered on the soft surfaces of the mouth (inside of the cheek, gums, tongue), or the nasal passages or throat where , they dissolve and are absorbed.

Jan 7      FDA Warns Public of Continued Extortion Scam by FDA Impersonators.  The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued  international extortion scam.  The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.  The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm and/or incarceration.  "Impersonating an FDA official is a violation of federal law," said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action.”  In most instances, victims of extortion-related calls have also received telephone solicitations for additional pharmaceutical purchases from other possibly related, illegal entities located overseas. The extortionists use customer lists complete with extensive personal information provided through previous purchase transactions. These include names, addresses, telephone numbers, Social Security numbers, dates of birth, purchase histories and credit card account numbers.  Typically, these criminals use telephone numbers that change constantly and make it appear as though their calls originate in the United States.

Jan 6      FDA Basics For Industry Web Page.   FDA has introduced a new Web resource called FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) to help companies and others save time and resources in their interactions with the agency. FDA Basics for Industry is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

 Jan 5      Recalls                                                                                                                                                           1.  PRODUCT -  Lorazepam                                                                                                               Lorazepam Tablets, USP, 0.5 mg. Packaged in 100 ct bottles (NDC 0781-1403-01) and 500 ct bottles (NDC 0781-1403-05).  Recall # D-132-2011;                                                                                       Lorazepam Tablets, USP, 1 mg. Packaged in 100 ct bottles (NDC 0781-1404-01) and 500 ct bottles (NDC 0781-1404-05). Recall # D-133-2011;                                                                                         Lorazepam Tablets, USP, 2 mg, a) 100-count bottles (NDC 0781-1405-01); b) 500-count bottles (NDC 0781-1405-05), Rx only. Recall # D-134-2011                                                                              CODE  - numerous lots                                                                                                         RECALLING FIRM/MANUFACTURER                                                                                   Sandoz Inc., Broomfield, CO, by letter on November 16, 2010. Firm initiated recall is ongoing.        REASON                                                                                                                      Impurities/Degradation Products: Lorazepam tablets were out of specification for Related Compound-C prior to expiry.

Jan 5      Drug Shortages -  Avalide (Irbesartan and hydrochlorothiazide) Tablets.   Bristol-Myers Squibb claims manufacturing delays at contract manufacturer.  No date of release known at this time.

Dec 22   Recalls                                                                                                                                           PRODUCT – Abilify Discmelt (aripiprazole) Tablets                                                                     Abilify Discmelt (aripiprazole) Tablets, 10 mg, 30 tablets count cartons, Packaged in 3 blister cards with 10 tablets in each blister card; NDC 59148-640-23. Recall # D-125-2011;                                         Abilify Discmelt (aripiprazole) Tablets, 15 mg, 30 tablets count cartons, Packaged in 3 blister cards with 10 tablets in each blister card; NDC 59148-641-23. Recall # D-126-2011                                        CODE                                                                                                                                                     Lot numbers: 9K57914A, Exp date: 11/12; and 0A60408A, Exp date: 01/13;                                                Lot number: 9K57907A, Exp date: 11/12                                                                                  RECALLING FIRM/MANUFACTURER                                                                               Recalling Firm: Bristol-Myers Squibb Company, Inc., Mount Vernon, IN, letters dated October 11, 2010.                                                                                                                                     Manufacturer: Bristol Myers Squibb Manufacturing Co., Humacao, PR. Firm initiated recall is ongoing. REASON                                                                                                                                         Marketed Without an Approved NDA/ANDA: Abilify Discmelt Orally Disintegrating Tablets 10 mg and 15 mg were packaged and released with 3 ply aluminum blister foil. The 3 ply foil is not the current NDA approved foil.

Dec 21   Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.   This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. It provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. It is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.  Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 14, 2011.  Please find additional information at:

http://edocket.access.gpo.gov/2010/pdf/2010-31426.pdf  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM236669.pdf

 


specialty pharma newsletter january 2013 prepared feb 11 2013 final.doc

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