Medivation, Inc. (MDVN: Quote) said Monday that it has submitted a New Drug Application to the U.S. Food and Drug Administration for enzalutamide, formerly MDV3100.
The compound has been studied in patients with castration-resistant prostate cancer who have received docetaxel therapy.
The FDA is expected to determine within 60 days whether to accept the filing for review.
Medivation said it 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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by RTT Staff Writer
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