GlaxoSmithKline (GSK) has filed a supplemental New Drug Application (sNDA) for Avodart (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. EU filings also are underway via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.
Dutasteride is not approved or licensed anywhere in the world to treat or reduce the risk of prostate cancer.