CDER News

June 12, 2009

• Drugs@FDA Download File (updated)
• FDA updates information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

June 11, 2009

• Drug Shortages: Current Drug Shortages: Methotrexate injection (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)

June 10, 2009

• FDA issues a Healthcare Professional sheet on Sirolimus (marketed as Rapamune)

June 9, 2009

• Manual of Policies and Procedures (MaPP) Tracking of Significant Safety Issues in Marketed Drugs -- Use of the DARRTS Tracked Safety Issue
• Guidance for Industry: Q8(R1) Pharmaceutical Development Revision 1

June 8, 2009

• Guidance for Industry:  Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events
• Drug Shortages: Resolved Drug Shortages: Cisplatin Injection 1mg/ml

Drug Approvals:

June 12, 2009

• • Besivance (besifloxacin hydrochloride) Ophthalmic Suspension, Bausch & Lomb, Inc., Approval
  • Glyburide and Metformin Hydrochloride Tablets, Indicus Pharma, LLC, Approval
  • Lupron Depot-3 (leuprolide acetate) Injection, Abbott Laboratories, Labeling Revision
  • PEG 3350 and Electrolytes Oral Solution, Novel Laboratories, Inc., Approval
  • Ropinirole Hydrochloride Tablets, Zydus Pharmaceuticals USA, Inc., Approval
  • Sanctura (trospium chloride) Tablets, Allergan, Inc., Labeling Revision
  • Sanctura XR (trospium chloride) Extended-Release Capsules, Allergan, Inc., Labeling Revision

• 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.