New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

October 2009

October 2

Sciele Pharma and Addrenex Announce Submission of sNDA to FDA for Clonicel to Treat ADHD Discovery Labs and FDA Establish Path for Potential Surfaxin Approval 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 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 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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