• Adverse Event Reporting System (AERS) (updated)
• FDA posts quarterly report of potential safety issues. FDA News
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Invega (paliperidone) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Labeling Revision
• Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated)
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS)
• Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS): January - March 2008

September 4, 2008

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Dissolution Methods Database (updated)
• FDA announces that manufacturers of TNF-blocker drugs (Cimzia, Enbrel, Humira, and Remicade) must highlight the risk of fungal and serious opportunistic infections. FDA News
• National Drug Code Directory (updated)
• New and Generic Drug Approvals
  • Abacavir Sulfate and Lamivudine Tablets, Aurobindo Pharma USA, Inc., Tentative Approval
  • Aceon (perindopril erbumine)Tablets, Solvay Pharmaceuticals, Inc., Labeling Revision
  • Levemir (insulin detemir [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • NovoLog (insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • NovoLog Mix 70/30 (insulin aspart protamine [rDNA origin] and insulin aspart [rDNA origin]) Injection, Novo Nordisk Inc., Labeling Revision
  • Stavudine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval
• Office of Generic Drugs: News and Announcements (updated)

September 3, 2008

• Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243
• Drugs@FDA Downloadable Data Files (updated)
• Guidance for Industry: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [PDF] or [HTML]
• New and Generic Drug Approvals
  • Clotrimazole Topical Cream, Nycomed US Inc., Approval
  • Ketotifen Fumarate Ophthalmic Solution, Alcon Inc., Approval
  • Ramipril Capsules, Zydus Pharmaceuticals USA Inc., Approval
  • Ranitidine (ranitidine hydrochloride) Syrup, Amneal Pharmaceuticals, Approval
  • Valtrex (valacyclovir hydrochloride) Tablets, GlaxoSmithKline, Patient Population Altered
• Office of Generic Drugs: August First-Time Generic Drug Approvals
• Paragraph IV Patent Certifications (updated)
• What You Should Know about Prescription Drug Advertisements

September 2, 2008

• New and Generic Drug Approvals
  • Dexamethasone Sodium Phosphate Injection, Akorn-Strides, Approval
  • NORVIR (ritonavir) Capsules, Abbott Laboratories, Labeling Revision
  • NORVIR (ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
  • Phosphocol P 32 (Chromic Phosphate and P-32) Injection, Mallinckrodt Inc., Labeling Revision
  • Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Formulation Revision
  • Talwin NX (naloxone hydrochloride and pentaz hydrochloride) Tablets, Sanofi-Aventis US, LLC, Labeling Revision

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September 4, 2008 Medical Device Safety, Tips & Articles: Cutting a Battery Pack Cable Can Start a Fire Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, April 24, 2007 - Minutes   News & Events • Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product • Certification to Accompany Drug, Biological Product, and Device Applications or Submissions Public Health Notifications: • Possible Malfunction of Electronic Medical Devices Caused by Computed Tomography (CT) Scanning • Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Class I Medical Device Recalls - • Pacific Consolidated Industries LLC, Mobile Oxygen Storage Tank • Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System • Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) FDA Patient

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