Avodart (dutasteride) regulatory update

Issued: Thursday 1 October, London UK

GlaxoSmithKline (GSK) announced today that it 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.  For more information about Avodart, please see the full prescribing information at www.gsk.com.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com