Avodart (dutasteride) regulatory update

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.

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

Enquiries:

UK Media enquiries:

Philip Thomson

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Gwenan White

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

 

European Analyst/Investor enquiries:

David Mawdsley

(020) 8047 5564

Sally Ferguson

(020) 8047 5543

Gary Davies

(020) 8047 5503

US Analyst/ Investor enquiries:

Tom Curry

(215) 751 5419

Jen Hill Baxter

(215) 751 7002