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US FDA Approves XTANDI for Patients With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Docetaxel


Medivation (NASDAQ: MDVN) and Astellas Pharma Inc. (Tokyo:4503) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to XTAND® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor.

The FDA accepted the XTANDI New Drug Application (NDA) on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012. Medivation and Astellas expect to make XTANDI available to patients in the United States in mid-September 2012, and the specific availability date will be announced on as soon as it is known. Separately, a Marketing Authorization Application for XTANDI has been accepted for review by the European Medicines Agency (EMA).

Posted-In: News FDA Global


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