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Center for Drug Evaluation &
Research (CDER) News

• Emerging Viral Infections (updated)
• New and Generic Drug Approvals
  • Anastrozole Tablets, Natco Pharma Ltd., Tentative Approval
  • Cardene (nicardipine hydrochloride) Injection, EKR Therapeutics, Inc., Formulation Revision
  • Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
  • Ethyol (amifostine) Injection, MedImmune, Labeling Revision
  • Loratadine Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Premarin (conjugated estrogens) Vaginal Cream, Wyeth Pharmaceuticals Inc., New or Modified Indication
  • Sutent (sunitinib malate) Capsules, Pfizer Inc., Labeling Revision
• Warning Letter: SINUS SCIENCE Aerosol Medication Delivery System

November 13, 2008

• Paragraph IV Patent Certifications (updated)

November 13, 2008

• BPCA/Pediatric Exclusivity Statistics (updated)
• Drugs Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection

November 12, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Drugs Shortages: Resolved Drug Shortages; Fentanyl Transdermal Patch
• FDA updates the Early Communication about the Ongoing Safety Review of Bisphosphonates. Information
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Amiodarone Hydrochloride Tablets, Apotex Corp., Approval
  • Clozaril (clozapine) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., New or Modified Indication
  • Dorzolamide Hydrochloride Ophthalmic Solution, Sandoz Canada Inc., Approval
  • Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, Sandoz Canada Inc., Approval
• Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Production and Process Controls (updated)

November 10, 2008

• Ethex Corp and FDA notify healthcare professionals of a voluntary recall of five generic products due to the potential for oversized tablets. MedWatch Safety Information
• New and Generic Drug Approvals
  • Apriso (mesalamine) Extended-Release Capsules, Salix Pharmaceuticals, Inc., Approval
  • Cefazolin (cefazolin sodium) Injection, B. Braun Medical, Inc., Labeling Revision
  • Diethylpropion Hydrochloride Tablets, CorePharma LLC, Approval
  • Divalproex Sodium Delayed-Release Tablets, Anchen Pharmaceuticals, Inc., Approval
  • Levetiracetam Tablets, Mylan Pharmaceuticals Inc., Approval
  • Ranexa (ranolazine) Extended-Release Tablets, CV Therapeutics, New or Modified Indication
  • Treanda (bendamustine hydrochloride) Injection, Cephalon Inc., Approval
  • Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision
  • Viread (tenofovir disoproxil fumarate) Tablets, Gilead Sciences, Inc., Labeling Revision

CDER Drug Links

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• Pharmacology//Toxicology

• Small Business

• En Español

• Contact the Center for Drug Evaluation and Research

• CDER Presentations

• CDER Meetings

November 14, 2008
	Summary Information for: ATS 3f Aortic Bioprosthesis
	General and Plastic Surgery Devices Panel Advisory Meeting, November 18-19, 2008 - Agenda, Roster, Briefing, Questions, Slides
	Summary Information for: TAXUS Liberté Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)
November 13, 2008
	Federal Register: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
	Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, November 14, 2008, Agenda, Roster, Briefing, Questions
November 10, 2008
	Federal Register: Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex.

Medical Device Links

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