June 4, 2009

• Drug Shortages: Current Drug Shortage: Infed (Iron Dextran) injection
• Drug Shortages: Resolved Drug Shortages: Metoprolol Succinate extended release tablets
• FDA issues a Healthcare Professional sheet on Propylthiouracil-Induced Liver Failure
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008

June 3, 2009

• BPCA/Pediatric Exclusivity Statistics (updated)
• Drugs@FDA Download File (updated)
• FDA issues a Healthcare Professional sheet on Propylthiouracil (PTU)-Induced Liver Failure

June 2, 2009

• Guidance for Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application
• Paragraph IV Patent Certifications (updated)

June 3, 2009

• Galantamine Hydrobromide Extended-Release Capsules, IMPAX Laboratories, Inc., Approval
• Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Montelukast Sodium Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
• Polyethylene Glycol-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Novel Laboratories, Inc., Approval
• Prednisolone Sodium Phosphate, Oral Solution, Vintage Pharmaceuticals, Approval
• Priftin (rifapentine) Tablets, Sanofi-Aventis U.S. LLC, Accelerated Approval
• Ranitidine Syrup, Dr. Reddy's Laboratories Ltd., Approval
• Ranitidine Syrup, Wockhardt USA LLC., Approval
• Risperidone Tablets, Hikma Pharmaceuticals, Approval
• Triamcinolone Acetonide Injection, Sandoz Canada Inc., Approval

Meetings:

• Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit, June 10-12, 2009, Hilton Washington DC/Rockville 1750 Rockville Pike, Rockville, MD. Meeting Information
• 2009 PDA/FDA Asia-Pacific Pharmaceutical Ingredient Supply Chain Conference, June 15-19, 2009, Shanghai, China. Meeting Information and registration
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• Quality Risk Management – Implementation Strategies; US FDA/CDER and University of Rhode Island College of Pharmacy Conference, June 15-16, 2009, Hyatt Regency Bethesda, Bethesda, Maryland. Meeting Information.