New Drug Applications Archive - April 2009
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April 2, 2009
- 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, 2009
- Arzerra (Ofatumumab) Granted Priority Review By FDA
- Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
April 6, 2009
April 7, 2009
- 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, 2009
April 9, 2009
- 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, 2009
April 16, 2009
April 23, 2009
- 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
