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Prostate Cancer Prevention Endpoint May Have Been Key Problem As ODAC Votes Down BPH sNDAs

Executive Summary

The problems that GlaxoSmithKline and Merck had in trying to convince FDA's Oncologic Drugs Advisory Committee to add labeling on prostate cancer risk reduction to Avodart (dutasteride) and Proscar (finasteride) may have been avoided had the firms selected a stronger mortality endpoint for their trials.

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