New Drug Applications Archive

New Drug Applications: April 2009

April 2	Onglyza (saxagliptin) Cardiovascular Profile Acceptable According to FDA Advisory Committee
April 2	GSK Submits Tyverb/Tykerb (lapatinib) for First-line Treatment of Metastatic Breast Cancer in Europe, US
April 2	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
April 3	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
April 7	AstraZeneca Receives FDA Complete Response Letter on Symbicort for the Treatment of Asthma in Children 6 to 11 Years Old
April 7	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	MonoSol Rx and Strativa Pharmaceuticals Submit New Drug Application for Ondansetron Orally Dissolving Film Strip
April 9	Bioalliance Pharma To Complete NDA For Loramyc With Data on Debossed Mucoadhesive Tablet
April 9	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
April 23	Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
April 23	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

New Drug Applications Archive

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