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FDA Accepts for Review sNDA for Label Modification to Prostate Cancer Treatment XTANDI, PDUFA Date is October 22, 2016

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Additional Relevant Details Medivation announced that the FDA 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. "  PDUFA decision date was set on October 22, 2016.
http://investors.med...
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Related Keywords Pdufa, Snda, Xtandi, Prostate Cancer