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Center for Drug Evaluation &
Research (CDER) News

• FDA requires new safety measures for oral sodium phosphate products to reduce risk of acute kidney injury
• New and Generic Drug Approvals
  • Acetazolamide Extended-Release Capsules, Zydus Pharmaceuticals USA, Inc., Approval
  • Acetazolamide Sodium Injection, X-Gen Pharmaceuticals, Inc., Approval
  • Arimidex (anastrozole) Tablets, AstraZeneca Pharmaceutical, LP, Labeling Revision
  • Augmentin XR (amoxicillin and clavulanate potassium) Extended-Release Tablets, GlaxoSmithKline, Labeling Revision
  • Crixivan (indinavir sulfate) Capsules, Merck & Co., Inc., Labeling Revision
  • OsmoPrep (sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous) Tablets, Salix Pharmaceuticals, Inc., Labeling Revision
  • PCE (erythromycin) Tablets, Abbott Laboratories, Labeling Revision
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)

December 10, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Drugs@FDA Downloadable Data Files (updated)
• Hospira, Inc. recalls one lot of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP. MedWatch Safety Information
• New and Generic Drug Approvals
  • Arimidex (anastrozole) Tablets, AstraZeneca, Approval
  • Cesamet (nabilone), capsules, Valeant Pharmaceuticals International, Formulation Revision
  • Delsym (dextromethorphan polistirex), Extended-Release Suspension, Adams Respiratory Therapy, Labeling Revision
  • Hectorol (doxercalciferol) Injection, Genzyme, Formulation Revision
  • Infuvite Adult (Multiple Vitamins for Infusion), Sandoz, Control Supplement
  • Risperidone, Tablets, Cobalt Laboratories, Inc., Approval
• Public Hearing: Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act, December 12, 2008, National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594.
  • Meeting information
  • Agenda

December 9, 2008

• Drugs Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection
• FDA/CMS Summit 2008:
  • CDER Priorities for 2009 Janet Woodcock M.D.
  • New Drug Review: 2008 Update, John K. Jenkins, M.D.
• Prescription Drug User Fee Act (PDUFA) Documents (updated)

December 8, 2008

• Guidance for Industry: Questions and Answers Regarding the Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Revision 1 [PDF]
• Pediatric Exclusivity Statistics (updated)
• Public Hearing: Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act, December 12, 2008, National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594. Meeting information.

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December 12, 2008 Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff: Submission and Review of Sterility Information in Premarket Notification Submissions for Devices Labeled as Sterile; Availability   December 11, 2008 Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile  Consumer Information on: E-LUMINEXX Vascular Stent - P080007 Federal Register: Guidance for Industry and the Food and Drug Administration: Modifications to Devices Subject to Premarket Approval; the Premarket Approval Supplement Decisionmaking Process; Availability Class I Medical Device Recall: Integra NeuroSciences, Gravity Compensating Accessory Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, December 9, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides   December 10, 2008 Class I Medical Device Recall: Advanced Medical Optics, (AMO) Inc., Healon D Ophthalmic Viscosurgical Device (OVD) Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process   December 9, 2008 Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, December 5, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary Obstetrics and Gynecology Devices Panel Advisory Meeting, December 11, 2008 - Agenda, Roster, Briefing, Questions   December 8, 2008 Circulatory System Devices Panel Advisory Meeting, November 20, 2008 - Brief Summary, Slides Immunology Devices Panel Advisory Meeting, December 3, 2008 - Notice of Meeting, Agenda, Roster, Briefing, Questions, Brief Summary

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