• Newly added Bioequivalents [HTML]
• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• CDER Data Standards Manual: Potency and Marketing Category
• Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 [Text] [PDF]
• New and Generic Drug Approvals
  • Bromocriptine Mesylate Capsules, Zydus Pharmaceuticals USA, Inc., Approval
  • Eplerenone Tablets, Apotex Corp., Approval
  • Fluconazole in Sodium Chloride 0.9% in Plastic Container (fluconazole) Injection, Bedford Laboratories, Approval
  • Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision

July 31, 2008

• CDER 2007 Update: Improving Public Health Through Human Drugs. [HTML] [PDF]
• Establishment of Prescription Drug User Fee Rates for Fiscal Year 2009 (Prepublication version) [PDF]
• New and Generic Drug Approvals
  • Cancidas (caspofungin acetate) I.V. Injection, Merck Research Laboratories, Patient Population Altered
  • Divalproex Sodium Delayed-Release Tablets, Dr. Reddy's Laboratories, Ltd., Approval
  • Divalproex Sodium Delayed-Release Tablets, Genpharm, ULC, Approval
  • Divalproex Sodium Delayed-Release Tablets, Lupin Pharmaceuticals, Inc., Approval
  • Divalproex Sodium Delayed-Release Tablets, Nu-Pharm, Inc., Approval
  • Divalproex Sodium Delayed-Release Tablets, Sandoz, Inc., Approval
  • Divalproex Sodium Delayed-Release Tablets, Sun Pharmaceutical Industries, Ltd., Approval
  • Divalproex Sodium Delayed-Release Tablets, Teva Pharmaceuticals USA, Approval
  • Divalproex Sodium Delayed-Release Tablets, Upsher-Smith Laboratories, Inc., Approval
  • Fortamet (metformin hydrochloride) Extended-Release Tablets, Andrx Pharmaceuticals, LLC, Labeling Revision
  • Mycophenolate Mofetil Capsules, Roxane Laboratories, Inc., Approval
  • Mycophenolate Mofetil Tablets, Roxane Laboratories, Inc., Approval
  • Primaquine (primaquine phosphate) Tablets, Sanofi-Aventis US, LLC, Labeling Revision
  • Stavzor (valproic acid) Delayed-Release Capsules, Banner Pharmacaps, Inc., Approval
  • Sumatriptan Succinate Injection, Teva Parenteral Medicines, Tentative Approval
• Postmarketing Study Commitments Database (updated)
• Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels (updated)
• Viapro 375mg Capsules recalled since it contained a potentially harmful analog of Sildenafil. MedWatch Safety Information

July 30, 2008

• Drugs@FDA Downloadable Data Files (updated)
• FDA issues Complete Response letters ordering Safety Labeling Changes under FDAAA for Aranesp, Epogen, and Procrit. Drug Information
• New and Generic Drug Approvals
  • Baraclude (entecavir) Oral Solution, Bristol-Myers Squibb Co., Efficacy Supplement with Clinical Data to Support
  • Baraclude (entecavir) Tablets, Bristol-Myers Squibb Co., Efficacy Supplement with Clinical Data to Support
  • Claritin (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Labeling Revision
  • Claritin (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Package Change
  • Claritin Hives Relief (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Labeling Revision
  • Claritin Hives Relief (loratadine) Syrup, Schering-Plough HealthCare Products, Inc., Package Change
  • Ketorolac Tromethamine Ophthalmic Solution, Alcon, Inc., Tentative Approval
  • Lamisil AT (terbinafine hydrochloride) Topical Solution, Novartis Consumer Health, Inc., Package Change
  • Lamisil AT (terbinafine hydrochloride) Topical Spray, Novartis Consumer Health, Inc., Package Change
  • Navstel (hypromellose, dextrose and glutathione) Ophthalmic Solution, Alcon, Inc., Approval
  • Nisoldipine Extended-Release Tablets, Mylan Pharmaceuticals, Inc., Approval
  • Provocholine (methacholine chloride) Inhalation Solution, Methapharm, Inc., Labeling Revision
  • Vicoprofen (hydrocodone bitartrate and ibuprofen) Tablets, Abbott Laboratories, Labeling Revision

July 29, 2008

• FDA reminds health care professionals who treat patients with mitoxantrone about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. MedWatch Safety Information
• New and Generic Drug Approvals
  • Anaprox (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Anaprox DS (naproxen sodium) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • EC-Naprosyn (naproxen) Delayed-Release Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Lopressor HCT (hydrochlorothiazide and metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Naprosyn (naproxen) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Naprosyn (naproxen) Oral Suspension, Hoffmann-La Roche, Inc., Labeling Revision
  • Pamidronate Disodium Injection, PharmaForce, Inc., Approval

July 28, 2008

• DIA/FDA/PhRMA Drug Safety Conference: Planning the Lifecycle of Safety Evaluation. October 14, Arlington, VA. Meeting information and registration
• Drug Safety Oversight Board Meeting, June 19, 2008
• New and Generic Drug Approvals
  • Capastat Sulfate (capreomycin sulfate) Injection, Eli Lilly and Co., Labeling Revision
  • Ceftriaxone (ceftriaxone sodium) Injection, ACS Dobfar, SPA, Approval
  • Ceftriaxone (ceftriaxone sodium) Injection, ACS Dobfar, SPA, Approval
  • Elmiron (pentosan polysulfate sodium) Capsules, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision
  • Lopressor (metoprolol tartrate) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Lopressor (metoprolol tartrate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Nicardipine Hydrochloride Injection, Teva Parenteral Medicines, Approval

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August 1, 2008 Guidance for Industry, FDA, and Foreign Governments - FY 2009 Medical Device User Fee Small Business Qualification and Certification Consumer Information on: Invitrogen SPOT-Light HER2 CISH Kit - P050040 Class I Medical Device Recall: Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) Federal Register: Medical Device User Fee Rates for Fiscal Year 2009   July 31, 2008 Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides Summary Information for: SPOT-Light HER2 CISH Kit   July 29, 2008 Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Agenda, Draft Roster, Final Roster, Briefing, Questions, Transcript   July 28, 2008 Summary Information for: ELA Ovatio CRT-D System

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