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Medivation (MDVN) Submits NDA for Enzalutamide to U.S. FDA

May 22, 2012 6:40 AM EDT Send to a Friend
Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. (TSE: 4503) announced that Medivation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for enzalutamide (formerly MDV3100). The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.

Pursuant to the Prescription Drug User Fee Act (PDUFA), the FDA is expected to determine within 60 days whether to accept the filing for review. Medivation has requested Priority Review, a designation given to drugs that offer a significant improvement in treatment or provide treatment where no satisfactory alternative therapy exists. If a Priority Review is granted, the FDA goal for completing a review is six months.




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