Dutasteride maker files NDA for prostate cancer risk reduction

October 15, 2009

p>GlaxoSmithKline has filed a supplemental new drug application with the FDA for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

GlaxoSmithKline has filed a supplemental new drug application with the FDA for dutasteride (Avodart) for prostate cancer risk reduction among men at increased risk of developing the disease.

European Union filings also are under way via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.

Dutasteride is not currently approved or licensed to treat or reduce the risk of prostate cancer.