New Drug Applications Archive - December 2009
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December 2, 2009
- Javelin Pharmaceuticals Submits Dyloject New Drug Application to FDA for Management of Acute Moderate-to-Severe Pain in Adults
- Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia
December 3, 2009
December 7, 2009
- Genzyme to Reopen Enrollment in Alglucosidase Alfa Temporary Access Program
- Somaxon Receives Complete Response Letter from the FDA for Silenor NDA
December 8, 2009
December 10, 2009
December 11, 2009
December 14, 2009
December 15, 2009
- Jazz Pharmaceuticals Submits New Drug Application for JZP-6 (sodium oxybate) for the Treatment of Fibromyalgia
- Alexza Announces Submission of AZ-004 (Staccato Loxapine) NDA
December 17, 2009
- ChemGenex Pharmaceuticals Announces Omapro to be Reviewed by the FDA's Oncologic Drugs Advisory Committee for the Treatment of Adults with Chronic Myeloid Leukemia who have Failed Prior Therapy with Imatinib and have the Bcr-Abl T315I Mutation
- Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
December 18, 2009
December 22, 2009
- Arena Pharmaceuticals Submits New Drug Application to FDA for Lorcaserin for Weight Management
- Shire Submits Biologics License Application for Replagal With the U.S. Food and Drug Administration
- Fibrocell Science, Inc. Receives FDA Complete Response Letter Regarding azficel-T for Wrinkles
