August 28, 2009

• • Cetirizine Hydrochloride Tablets, Unique Pharmaceutical Laboratories, Approval
  • Clindamycin Hydrochloride Capsules, Aurobindo Pharma, Ltd., Approval
  • Clonidine Hydrochloride Tablets, Impax Laboratories, Inc., Approval
  • Clonidine Hydrochloride Tablets, Unichem Laboratories, Ltd., Approval
  • Orencia (abatacept) I.V. Powder, Bristol-Myers Squibb Co., Supplement
  • Ranitidine Hydrochloride Syrup, Cypress Pharmaceutical, Inc., Approval
  • Ropivacaine Hydrochloride Injection, Navinta, LLC, Tentative Approval
  • Zenpep (pancrelipase) Delayed-Release Capsules, Eurand Pharmaceuticals, Ltd., Approval 

August 26, 2009

• • Desloratadine Tablets, Glenmark Generics Ltd., Tentative Approval
  • Desloratadine Tablets, Orchid Healthcare, Tentative Approval
  • Livalo (pitavastatin) Tablets, Kowa Company, Ltd., Approval
  • Promethazine Hydrochloride and Phenylephrine Hydrochloride Syrup, Amneal Pharmaceuticals, Approval
  • Saphris (asenapine) Tablets, Organon USA Inc., Approval

August 25, 2009

• • Oxycodone Hydrochloride, Tablets, CorePharma LLC, Approval
  • Sabril (vigabatrin) Tablets, Lundbeck Inc., Approval
  • Sabril (vigabatrin) Oral Solution, Lundbeck Inc., Approval

• FDA, Issues in the Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop, September 1-2, 2009
• 2009 PDA/FDA Joint Regulatory Conference, September 14-18, 2009, Renaissance Hotel, 999 9th Street NW, Washington, D.C. Meeting Information and registration
• Drug Information Association (DIA) and Food and Drug Administration (FDA): Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science, September 23-24, 2009, Omni Shoreham Hotel, Washington, DC. Meeting Information and registration
• Educating the Public About Removal of Essential-Use Designation for Epinephrine, Public Workshop, September 25, 2009, FDA, Center for Drug Evaluation and Research Advisory Committee Conference Room, 5600 Fishers Lane, Rm 1066, Rockville, Maryland 20852
• Providing Effective Information to Consumers about Prescription Drug Risks and Benefits; Public Workshop, September 24-25, 2009, Gaithersburg, MD 20877. Meeting Information
• CDER Forum for International Drug Regulatory Authorities, October 5-9, 2009, Silver Spring, Maryland.   

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