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Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status
Allos Therapeutics, 05/27/09
Allos Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The Company also announced that the FDA has granted the NDA priority review status and established a Prescription Drug User Fee Act date of September 2009 for a decision regarding approval of the NDA. Priority review designation is assigned to drugs that have the potential to provide a significant improvement compared to marketed products or provide a safe and effective therapy where no satisfactory therapy exists.
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Cell Therapeutics Announces FDAs Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkins Lymphoma, February 2010
Cell Therapeutics, 12/18/09
Sanofi Pasteur obtains license from Syntiron to develop & commercialize vaccine to prevent Staphylococcus infections
Sanofi-aventis, 12/17/09
Telmisartan/amlodipine: approved for high blood pressure
Formulary , 12/16/09
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Generic drugs dominate market, look to expand into biologics
Formulary , 12/16/09
Mylan Receives Approval for Generic Version of Antiepileptic Keppra 1000 mg
Mylan, 12/15/09
Vigabatrin: a comprehensive review of drug properties including clinical updates following recent FDA approval
Expert Opinion in Pharmacotherapy, 12/09/09
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