New Drug Applications Archive

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All News Consumer Pharma New Drugs Pipeline Clinical Trials

April 2009

April 2

Onglyza (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee GSK Submits Tyverb/Tykerb (lapatinib) for First-line Treatment of Metastatic Breast Cancer in Europe, US Xanodyne's New Drug Application for XP12B the Treatment of Heavy Menstrual Bleeding (Menorrhagia) Accepted for Filing with a Priority Review Classification

April 3

Arzerra (Ofatumumab) Granted Priority Review By FDA Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes

April 6

Santarus Announces FDA Acceptance of New Drug Application for Zegerid Tablet Product

April 7

Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia

April 8

FDA Advisory Committee provides opinion on Serdolect for the treatment of schizophrenia

April 9

Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications

April 14

Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone

April 16

Vion Pharmaceuticals' New Drug Application for Onrigin Accepted For Review by the FDA

April 23

U.S. Food and Drug Administration Extends Review Timeline for Onglyza (saxagliptin) New Drug Application Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis Vion Pharmaceuticals Receives a Standard Review from the FDA for Its New Drug Application for Onrigin

April 25

FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections

April 28

U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months

April 29

BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for Xiaflex for the Treatment of Dupuytren's Disease

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