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Center for Drug Evaluation &
Research (CDER) News

• Guidance for Industry: Labeling OTC Human Drug Products -- Questions and Answers [PDF]
• New and Generic Drug Approvals
  • Avinza (morphine sulfate) Extended-Release Capsules, King Pharmaceuticals, Inc., Control Supplement
  • Diltiazem Hydrochloride Injection, Baxter Healthcare Corp., Approval
  • Fludarabine Phosphate (fludarabine phosphate) Tablets, Antisoma, Approval
  • Fluoxetine Hydrochloride Delayed-Release Capsules, Dr. Reddy's Laboratories, Ltd., Tentative Approval
  • Gemcitabine Hydrochloride Injection, TEVA Parenteral Medicines, Inc., Approval
  • Infuvite Pediatric (ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin A and vitamin K), Sandoz Canada, Inc., Control Supplement
  • Levetiracetam Tablets, Cobalt Laboratories, Inc., Tentative Approval
  • Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Proglycem (diazoxide) Oral Suspension, Teva Global Respiratory Research, LLC, Manufacturing Change or Addition
  • Promethazine Hydrochloride Tablets, Sun Pharmaceutical Industries, Inc., Approal
  • Rifater (isoniazid, pyrazinamide and rifampin) Tablets, Sanofi-aventis U.S. LLC, Labeling Revision
  • Ryzolt (tramadol hydrochloride) Extended-Release Tablets, Labopharm Canada, Inc., Approval
  • Trilipix (fenofibric acid) Delayed-Release Capsules, Abbott Laboratories, Approval
  • Vancomycin Hydrochloride Injection, Akorn - Strides, LLC, Approval
  • Vasovist (gadofosveset trisodium) Injection, Epix Pharmaceuticals, Approval

December 31, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Acetadote (acetylcysteine) Intravenous Injection, Cumberland Pharmaceuticals Inc., Labeling Revision
  • Alvesco (ciclesonide) Inhalation Aerosol, Sepracor, Inc., Labeling Revision
  • Aromasin (exemestane) Tablets, Pfizer Inc., Labeling Revision
  • Bicalutamide Tablets, Accord Healthcare Inc., USA, Tentative Approval
  • Butalbital, Acetaminophen and Caffeine Tablets, Concord Laboratories, Inc., Approval
  • Cyklokapron (tranexamic acid) Injection, Pfizer Inc., Labeling Revision
  • Emtricitabine Capsules, Matrix Laboratories Ltd., Approval
  • Enalaprilat Injection, Hikma Farmaceutica (Portugal), Approval
  • Famvir (famciclovir) Tablets, Novartis Pharmaceuticals Corporation, Labeling Revision
  • Follistim AQ (follitropin alfa and beta) Injection, Organon USA Inc., Package Change
  • Hydrocodone Bitartrate and Acetaminophen Tablets, Sun Pharmaceutical Industries, Inc., Approval
  • Ibuprofen and Diphenhydramine Citrate Tablets, Perrigo R&D Company, Approval
  • Irinotecan Hydrochloride Injection, Bedford Laboratories, Approval
  • Latisse (bimatoprost) Ophthalmic Solution, Allergan, Inc., Approval
  • Letrozole Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Meridia (sibutramine hydrochloride) Capsules, Abbott Laboratories, Labeling Revision
  • Nexterone (amiodarone hydrochloride) Injection, Prism Pharmaceuticals, Inc., Approval
  • Pamidronate Disodium Injection, GeneraMedix Inc., Approval
  • Pamidronate Disodium Injection, Sun Pharmaceutical Industries, Ltd., Approval
  • Quetiapine Fumarate Tablets, Teva Pharmaceuticals USA, Tentative Approval

December 30, 2008

• Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing, 12/12/2008; Presentations
• Drug Firm Annual Registration Status (updated)
• New and Generic Drug Approvals
  • Avelox (moxifloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
  • Avelox in Sodium Chloride 0.8% in Plastic Container (moxifloxacin hydrochloride) I.V. Injection, Bayer HealthCare Pharmaceuticals Inc., Labeling Revision
  • Desogestrel, Ethinylestradiol and Ethinyl Estradiol Tablets, Watson Laboratories, Inc., Approval
  • Fuzeon (enfuvirtide) Subcutaneous Injection, Hoffmann-La Roche, Inc., Labeling
    Revision
  • Gemfibrozil Tablets, Sun Pharmaceutical Industries, Inc., Approval
  • Glycopyrrolate Tablets, Vintage Pharmaceuticals, Approval 
  • Innohep (tinzaparin sodium) Injection, Celgene Corporation, Labeling Revision
  • Nicotine Polacrilex, Gum, Watson Laboratories, Inc., Approval
  • Nicotine Polacrilex Gum, Watson Laboratories, Inc., Approval
  • Risperidone Tablets, Vintage Pharmaceuticals, LLC, Approval 
  • Rocuronium Bromide Injection, APP Pharmaceuticals, LLC, Approval
  • Stavudine Capsules, Hetero Drugs Ltd., Approval
  • Stavudine Capsules, Matrix Laboratories, Inc., Approval
  • Stavudine Capsules, Aurobindo Pharma Ltd., Approval
  • Stavudine Oral Solution, Aurobindo Pharma Ltd., Approval
  • Vecuronium Bromide Injection, GeneraMedix Inc., Approval
  • Ziprasidone Hydrochloride Capsules, Dr. Reddy’s Laboratories Ltd., Tentative Approval

December 29, 2008

• FDA approves degarelix for injection for patients with advanced prostate cancer. FDA News
• New and Generic Drug Approvals
  • Degarelix Injection, Ferring Pharmaceuticals, Inc., Approval

CDER Drug Links

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January 2, 2009
	Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices
	Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA
	Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA; Availability.
	Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay.
December 30, 2008
	Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use

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