GSK to resubmit sNDA for Avodart to prevent prostate cancer


There have been several reports in the past few days that GlaxoSmithKline (GSK) has withdrawn its supplemental New Drug Application (sNDA) for approval to market dutasteride (Avodart) in the US for the prevention of prostate cancer, based on the results from the REDUCE trial, announced earlier this year.

GSK has indeed withdrawn the sNDA. However, the company expects to resubmit in very soon with some minor modifications, and it has already submitted these modifications to the European regulatory agency (EMEA).

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