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FDA Accepts to File Cell Therapeutics New Drug Application for Pixantrone
Cell Therapeutics, 09/04/09
Cell Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted and has filed for review the Company's New Drug Application for pixantrone as treatment for relapsed or refractory aggressive non–Hodgkin's lymphoma. A Prescription Drug User Fee Act date will be established by the FDA regarding the review of the pixantrone NDA by September 4th 2009.
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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/22/09
Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09
Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09
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