Medivation And Astellas Announce PDUFA Action Date For Enzalutamide NDA

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Medivation Inc. (MDVN: Quote) and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012 for the review of the investigational agent enzalutamide (formerly MDV3100) New Drug Application (NDA) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

The companies announced on July 24, 2012 that the FDA accepted the enzalutamide NDA filing for review and granted Priority Review Designation.

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