October 16, 2009

• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
• Guidance for Industry:  Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB)
• MedWatch Alert on labeling change for dexferrum (iron dextran injection)

October 15, 2009

• Question and Answers about Changes to the USP Heparin Monograph
• Dissolution Methods Database
• Inactive Ingredient Search for Approved Drug Products (updated)
• Postmarketing Safety Evaluation of New Molecular Entities: Final Report

October 14, 2009

• Drugs@FDA Download File (updated)
• DSOB Memorandum of Meeting Minutes, September 17, 2009
• New FDA Web Page Lists Disposal Instructions for Select Medicines

October 13, 2009

• FDA Acts to Halt Marketing of Unapproved Codeine Sulfate Tablets
  • Warning Letters
    • Cerovene, Inc.
    • Dava International, Inc.
    • Glenmark Generics, Inc.
    • Lehigh Valley Technologies, Inc.
• FDA Approves Berinert to Treat Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema
• MedWatch Safety Alert for Relenza (zanamivir) Inhalation Powder
• Warning Letter
  • Sumitono Chemical Company Limited
• Drug Shortages: Current Drug Shortages: Fabrazyme (agalsidase beta) (updated)
• Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland (updated)

October 16, 2009

• • Polyethylene Glycol 3350 Oral Solution, Paddock Laboratories, Inc., Approval
  • Topiramate Capsules, Sandoz Inc., Approval
  • Topiramate Capsules, Zydus Pharmaceuticals Inc., Approval
  • Topiramate Capsules, Mylan Pharmaceuticals Inc., Approval

 

October 15, 2009

• • Aggrenox (aspirin and dipyridamole) Extended-Release Capsules, Boehringer-Ingelheim, Efficacy Supp w/Clinical Data
  • Heparin Sodium Injection, Baxter Healthcare Corporation, Labeling Revision
  • INVANZ (ertapenem sodium) Intramuscular I.V. Injection, Merck & Co., Inc., Labeling Revision
  • Mirena (levonorgestrel) Intrauterine System, Bayer HealthCare Pharmaceuticals, Inc., Efficacy Supp w/Clinical Data
  • Monistat 3 (miconazole nitrate) Vaginal Cream, Johnson & Johnson Healthcare Products, Manufacturing Change or Addition
  • MultiHance (gadobenate dimeglumine) Intravenous Injection, Bracco Diagnostics, Inc., Labeling Revision
  • Pulmicort Respules (budesonide) Inhalation Suspension, AstraZeneca, Labeling Revision
  • Risperidone Orally Disintegrating Tablet, Dr. Reddy's Laboratories Ltd., Supplement
  • Tamsulosin Hydrochloride Capsules, IMPAX Laboratories, Inc. Tentative Approval
  • Topiramate Capsules, Mylan Pharmaceuticals Inc., Approval

 

October 14, 2009

• • Anzemet (dolasetron mesylate) Injection,  Sanofi-Aventis U.S. LLC, Labeling Revision
  • Anzemet (dolasetron mesylate) Tablets,  Sanofi-Aventis U.S. LLC, Labeling Revision
  • Ketorolac Tromethamine Ophthalmic Solution, Akorn, Inc., Tentative Approval
  • Ketorolac Tromethamine Ophthalmic Solution, Akorn, Inc., Tentative Approval
  • OsmoPrep (sodium phosphate, dibasic anhydrous, sodium phosphate, monobasic and monohydrate) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
  • Polyethylene Glycol 3350 Oral Solution, Mylan Pharmaceuticals, Inc., Approval
  • Visicol (sodium phosphate, dibasic anhydrous, sodium phosphate, monobasic and monohydrate) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision

 

October 13, 2009

• • Clonidine Hydrochloride Injection, PharmaForce, Inc., Approval
  • Delsym (dextromethorphan polistirex) Extended-Release Oral Suspension, Reckitt Benckiser, Inc., Labeling Revision
  • Fluocinonide Topical Cream, Perrigo Israel Pharmaceuticals, Ltd., Tentative Approval
  • Losartan Potassium and Hydrochlorothiazide Tablets, Apotex Inc., Tentative Approval
  • Neoral (cyclosporine) Capsules, Novartis Pharmaceuticals Corp., Labeling Revision
  • Neoral (cyclosporine) Oral Solution, Novartis Pharmaceuticals Corp., Labeling Revision
  • Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca, Labeling Revision
  • Nexium (esomeprazole magnesium) Delayed-Released Oral Solution, AstraZeneca, Labeling Revision
  • Risperidone Oral Solution, Wockhardt Ltd., Approval
  • Sumatriptan Succinate Subcutaneous Injection, Par Pharmaceutical, Inc., Approval

• DIA/FDA Assessing Benefits and Risks of Medicinal Products in Regulatory Decisions, November 3-5, 2009, Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland. Meeting information and registration
• DIA/FDA/PhRMA Modeling and Simulation in Drug Development: Quantitative Approaches for Decision Making, October 28-29, 2009, Marriott Bethesda Pooks Hill, 5151 Pooks Hill Road, Bethesda, Maryland. Meeting information and registration
• CDER's Small Business Assistance Educational Forum: The Investigational New Drug Process, Public Workshop, October 15, 2009, 5100 Paint Branch Parkway, College Park, MD 20740. Auditorium 1A003. Meeting information and registration
• Preparation for ICH meetings in St. Louis, Missouri to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in St. Louis, Missouri, Public Meeting, October 14, 2009, Washington Room, Hilton Rockville, 1750 Rockville Pike, Rockville, Maryland
• DIA/FDA/NCI/PhRMA Progression-Free Survival Oncology Workshop, October 7-9, 2009, DoubleTree Hotel and Executive Meeting Center, 8120 Wisconsin Avenue, Bethesda, Maryland 20814. Meeting information and registration
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, Maryland.