GlaxoSmithKline (GSK) announced that in order to provide an update to the application, the company is withdrawing its US Supplemental New Drug Application (sNDA) for Avodart (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease. GSK expects to resubmit the file shortly. This action is not the result of new findings related to safety or efficacy.
Review of the EU filings will begin once the same update has been provided to the EU regulatory agencies.
Dutasteride is not approved or licensed in the US or Europe to treat or reduce the risk of prostate cancer.