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Center for Drug Evaluation &
Research (CDER) News

• New and Generic Drug Approvals
  • Albuterol Sulfate Inhalation Solution, Lannett, Approval
  • Cellcept (mycophenolate mofetil) Capsules, Roche Palo Alto LLC, Labeling Revision
  • Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto LLC, Labeling Revision
  • Cellcept (mycophenolate mofetil hydrochloride) Injection, Roche Palo Alto LLC, Labeling Revision
  • Cellcept (mycophenolate mofetil) Oral Suspension, Roche Palo Alto LLC, Labeling Revision
  • Enablex (darifenacin hydrobromide) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Naproxen Sodium Tablets, Amneal Pharmaceuticals LLC, Approval
  • Toradol (ketorolac tromethamine) Tablets, Hoffmann-La Roche Inc., Labeling Revision
• CDER Organization Charts [HTML] [PDF] (updated)

December 18, 2008

• New and Generic Drug Approvals
  • Galantamine Hydrobromide Extended-Release Capsules, Watson Laboratories, Inc., Approval
  • Genotropin (somatropin recombinant) Injection, Pharmacia & Upjohn, Labeling Revision
  • Hydralazine Hydrochloride Tablets, Invagen Pharmaceuticals, Inc., Approval
  • Infuvite Pediatric (Pharmacy Bulk Package) (ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine, riboflavin, thiamine, tocopherol acetate, vitamin A and vitamin K) I.V. Injection, Sandoz Canada, Inc., Control Supplement
  • Integrilin (eptifibatide) Injection, Schering Corp., Labeling Revision
  • Mozobil (plerixafor) Injection, Genzyme Corp., Approval
  • Trilipix (fenofibric acid) Delayed-Release Capsules, Abbott Laboratories, Approval
  • Ursodiol Capsules, Lannett Holdings, Inc., Approval
• Office of Generic Drugs: Determination of Dorzolamide-Timolol Maleate Ophthalmic Solution Exclusivitiy

December 17, 2008

• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [PDF] or [HTML]
• Guidance for Industry: Orally Disintegrating Tablets [PDF]
• New and Generic Drug Approvals
  • Acetadote (acetylcysteine) Injection, Cumberland Pharmaceuticals, Inc., Labeling Revision
  • Aredia (pamidronate disodium) Injection, Novartis Pharmaceuticals Corp., Labeling Revision
  • Efavirenz Tablets, Aurobindo Pharma Ltd., Tentative Approval
  • Enablex (darifenacin hydrobromide) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • Lusedra (fospropofol disodium) Injection, Eisai Medical Research Inc., Approval
  • Omnicef (cefdinir) Capsules, Abbott Laboratories, Labeling Revision
  • Omnicef (cefdinir) Oral Suspension, Abbott Laboratories, Labeling Revision
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

December 16, 2008

• FDA is requiring that all manufacturers of antiepileptic drugs include a Warning in their labeling and develop a Medication Guide to be provided to patients to inform them of the risks of suicidal thoughts or actions. MedWatch Safety Information
• FDA releases a study that finds much of private-sector consumer medication information is not consistently useful. Information
• Letter and questions and answers on the phase-out of epinephrine CFC metered-dose inhalers
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Elmiron (pentosan polysulfate sodium) Capsules, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Labeling Revision
  • Hectorol (doxercalciferol) Injection, Genzyme Corporation, Formulation Revision

December 15, 2008

• Division of Drug Marketing, Advertising, and Communications Letter: Xodol (hydrocodone bitartrate and acetaminophen) tablets
• Guidance for Industry:
  • Postmarketing Adverse Even Reporting for Medical products and Dietary Supplements During an Influenza Pandemic [PDF]
  • Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches [PDF]
  • Bioequivalence Guidance: 17 new recommendations have been added, including Vancomycin [PDF]
• New and Generic Drug Approvals
  • Actos (pioglitazone hydrochloride) Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Calcitonin Salmon Nasal Spray, Nastech Pharmaceutical Company Inc., Tentative Approvoal
  • Ciprofloxacin Hydrochloride Ophthalmic Solution, Akorn, Inc., Approval
  • Epiduo (adapalene and benzoyl peroxide) Gel, Galderma Laboratories, L.P., Approval
  • Zerit (stavudine) Capsules, Bristol-Myers Squibb Company, Labeling Revision
  • Zerit (stavudine) Oral Solution, Bristol-Myers Squibb Company, Labeling Revision
• Office of Generic Drugs: November First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)

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December 19, 2008 Federal Register: Agency Information Collection Activities ; Proposed Collection; Comment Request; Medical Device Recall Authority. Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”). Summary Information for: Bard ELUMINEXX Vascular Stent Summary Information for: Boston Scientific Express SD Renal Monorail Premounted Stent System Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander Class I Medical Device Recall: Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades   December 16, 2008 Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices. Federal Register: Microbiological Testing for Contact Lens Care Products; Public Workshop.  PMA Final Decisions for November 2008   December 15, 2008 Obstetrics and Gynecology Devices Panel Advisory Meeting, December 11, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary

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