New Drug Applications Archive

New Drug Applications: October 2009

October 2	Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD
October 2	Discovery Labs and FDA Establish Path for Potential Surfaxin Approval
October 2	Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States
October 5	GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient
October 6	Orexo confirms FDA acceptance of Abstral filing
October 12	Fibrocell Science, Inc. Reports Outcome of FDA Advisory Committee Meeting on Azfibrocel-T for Wrinkles
October 14	Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
October 21	FDA Issues Complete Response Letter for CorVue
October 21	Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)
October 22	Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
October 22	Endo Pharmaceuticals Gives Update on Regulatory Status of Fortesta
October 23	Novartis receives Complete Response letter from FDA for QAB149, an investigational bronchodilator for COPD
October 26	Gilead's Aztreonam for Inhalation Solution to be Reviewed by FDA Anti-Infective Drugs Advisory Committee on December 10, 2009
October 30	Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application

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