Home >> News
News

Industry News

Specialty Pharma Newsletter (November-December 2014) 

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

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  You can download your unpublished copy at: CLICK TO DOWNLOAD 

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  You can download your unpublished copy at:    CLICK TO DOWNLOAD 

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

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

     - describes who must report to FDA,

     - what information should be submitted to FDA,

     - the timing of the submissions,

     - a preferred format for the submissions, and

     - a preferred method for reporting to FDA.

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

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

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

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

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

Dec 10    Recalls – Drugs Class III

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

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

Dec 10    Guidance for Industry

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

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

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

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

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

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

Dec 4      Guidance for Industry

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

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

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

Dec 2      Recalls – Drugs Class II   

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

 

Dec 1      Guidance for Industry

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

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

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

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

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

Nov 21   Public Notifications - Products Containing Hidden Drug Ingredient

                   Super Extreme Accelerator for weight loss.   Hidden ingredient: Sibutramine

                   Bee Thin for weight loss.  Hidden ingredient:  Sibutramine

                   Black Storm for sexual enhancement.   Hidden ingredient:  Sildenafil

                   Be Slim for weight loss.   Hidden ingredient:  Sibutramine   

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

                                Hidden ingredients: Diclofenac &  Indomethacin.

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

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

Nov 19   Recalls – Drugs Class III

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

Nov 19   Recalls – Drugs Class II

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

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

Nov 19   Guidance for Industry

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

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

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

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

 

 

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

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

Nov 18   Orange Book

Additions and Deletions.
Download at:  CLICK TO DOWNLOAD

Cumulative Supplement November 2014.
Download at:  CLICK TO DOWNLOAD

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

Nov 12   Recalls – Class III

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

 

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

  

Specialty Pharma Newsletter (October-November 2014)

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

Nov 6     Recalls – Class I

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

Nov 6     Recalls – Class II

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

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

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

Nov 4     Public Notification: V26 Slimming Coffee Contains Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use V26 Slimming Coffee, a product promoted and sold for weight loss on various websites and possibly in some retail stores.  FDA laboratory analysis confirmed that V26 Slimming Coffee contains sibutramine.  The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Nov 5     Warning Letters

Issued to Hikma Pharmaceuticals, Ltd., Ammam, Jordan

Reason: cGMP violations in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.   Specifically, There is a lack of investigations of unexplained discrepancies, and a failure to establish adequate written procedures for production and process control.

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

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

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

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

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

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

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

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

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

Oct 29    Recalls – Class II

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

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

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

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

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

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

 

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

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

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

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

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

Oct 22    Recalls – Class III

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

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

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

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

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

Manufactured by Cadila Healthcare Ltd., Ahmedabad, India  

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

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

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

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

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

Find more information on DSCSA at:  CLICK FOR MORE INFORMATION

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

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

Oct 15    Recalls - Class II

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

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

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

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

Oct 7      Recalls – Class I

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

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

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

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

Oct 1      Recalls – Class III

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

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

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

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

Sep 24    Recalls – Class I

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

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

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

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

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

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

Sept 16   Guidance for Industry:

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

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

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

Specialty Pharma Newsletter -May-September 2014 

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

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

Sept 12   Recalls – Class II

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

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

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

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

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

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

Sept 5     Warning Letters

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

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

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

Sept 3     Recalls – Class III 

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

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

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

Aug 20   Recalls – Class I

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

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

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

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

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

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

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

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

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

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

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

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

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

Aug 13   Recalls – Class III

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

Aug 13   Recalls – Class II

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

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

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

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

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

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

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

Jul 30 Recalls – Class I and II

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

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

Jul 30     Recalls – Class III  

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

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

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

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

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

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

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

Control/Click to follow the above links. 

Jul 25     Recalls – Class III

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

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

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

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

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

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

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

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

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

1)      Trim Fast Slimming Softgel

2)      Sliming (sic) Diet by Pretty White

3)      Lipo 8 Burin Slim Capsules

4)      24 Ince

5)      Lingzhi Cleansed Slim Tea

6)      Mix Fruit Slimming

7)      Gold Viagra

8)      Miraculous Evil Root

9)      Sport Burner

10)    Toxin Discharged Tea

11)    Burn 7 Capsules (also contain phenolphthalein)

12)    Gold Reallas (contains Thiosildenafil)

13)    Full Throttle On Demand (contains propoxyphenyl sildenafil)

These products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.  Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. 

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

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

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

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

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

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

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

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

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

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

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

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

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

Jun 4      Recalls – Class II

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

Specialty Pharma Newsletter - January-April 2014 

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

Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers. Webinar access 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:  CLICK TO DOWNLOAD

 Apr 16   Warning Letters

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

 Issued to Aloe Man International Corp., 18800 NW 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 & Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control along with diet & exercise, in adults with type 2 diabetes. Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety & effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes. Patients participating in the trials showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin, a measure of blood sugar control).

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

Apr 11   The products “Infinity” and “Lite Fit USA” Contain a Hidden Drug Ingredient.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use Infinity or Lite Fit USA, products promoted and sold for weight loss on various websites, and in some retail stores.  FDA laboratory analysis confirmed that Infinity contains 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:  CLICK TO DOWNLOAD

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

Apr 9     Recalls – Drugs Class III

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

Recalls – Drugs Class II

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

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

Apr 7     The U.S. Food & Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss & body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label. The FDA has tested multiple Zi Xiu Tang Bee Pollen products from various distributors in the USt. All products that have been tested, including those that claim to be “genuine” and “anti-counterfeit,” have been found to contain one or both of the following undeclared drug ingredients:  Sibutramine – a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.   Phenolphthalein – a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.  The FDA has received dozens of adverse event reports, including many serious cardiac issues, associated with the use of Zi Xiu Tang Bee Pollen. Reports have included heart palpitations, tachycardia (increased heart rate), suicidal thoughts, chest pain, diarrhea, anxiety, insomnia, increased blood pressure and seizure. Consumers who have experienced any negative side effects while taking this product should consult a health care professional.

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

Send questions to: 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:  CLICK TO DOWNLOAD

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

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

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

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

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

Mar 31  Nova Products, Inc. Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical 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:  VIEW PRESENTATION

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

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

Mar 17   Recalls – Class III 

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

Mar 17   Recalls – Class II 

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

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

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

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

Mar 12   Recalls – Class II

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

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

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

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

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

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

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

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

Feb 26    FDA’s GDUFA Regulatory Science Initiatives Public Meeting.    FDA is hosting “The Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15” Public Meeting to give an overview of the current status of the regulatory science initiatives for generic drugs and an opportunity for public input on the FY 2015 research priorities.  FDA wants your input as we develop an annual list of regulatory science initiatives specific to generic drugs. We will take the information from the public meeting into account in developing the fiscal year (FY) 2015 Regulatory Science Plan.   The meeting will be held at FDA’s main campus in Silver Spring, MD, on May 16, 2014, from 9:00am-5:00pm and will be webcast for those who cannot attend in person.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing 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:  CLICK TO DOWNLOAD

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

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

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

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

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

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

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

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

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

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

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

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

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

Feb 11    GDUFA Regulatory Science Initiatives Public Meeting and Webcast on May 16, 2014, in Silver Spring, MD.  Submit electronic or written requests to make oral presentations and comments by April 25, 2014. Electronic or written comments will be accepted at any time until the docket closes on June 13, 2014. You may submit ideas on generic drug research topics that should be added to the FY 2015 Regulatory Science Plan by emailing 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:  CLICK TO DOWNLOAD 

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

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

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

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

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

CLICK TO DOWNLOAD

Jan 29    Recalls – Drugs Class II

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

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

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

Jan 22    Recalls – Drugs Class II

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

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

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

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

Specialty Pharma Newsletter - November-December 2013 

Jan 8      Recalls Class III

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

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

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

Jan 8      Guidance for Industry

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

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

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

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

Jan 1      Recalls – Class II

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

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


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

Back to the News homepage.