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GSK withdraws sNDA for Avodart in prostate cancer prevention

This article was originally published in Scrip

Executive Summary

GlaxoSmithKline has withdrawn an sNDA requesting permission to market Avodart (dutasteride) for prostate cancer risk reduction in the US, citing administrative problems that need to be resolved. A similar EU filing is on hold until the same update is provided to the regulator there.

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