Astellas, Medivation announce acceptance of XTANDI sNDA for review by FDA

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The FINANCIAL — Astellas Pharma Inc. and Medivation, Inc. on February 23 announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI (enzalutamide) capsules in metastatic castration- resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016, according to Astellas Pharma.

A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.


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