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GSK regulatory update – Avodart (dutasteride)

GlaxoSmithKline (GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration (FDA).

Issued: London UK, Philadelphia, US

GlaxoSmithKline (GSK) announced today that it has re-submitted the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration (FDA).

The re-submission provides an update to the initial application in 2009. The withdrawal of the initial application was not the result of new findings related to safety or efficacy. The update to the submission has not changed the interpretation of the data submitted.

The provision of this update to the European Regulatory authorities is also underway.

Dutasteride is not approved or licensed in the US or Europe 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.

GlaxoSmithKline enquiries:

   

UK Media enquiries:

Philip Thomson

(020) 8047 5502

 

Claire Brough

(020) 8047 5502

 

Stephen Rea

(020) 8047 5502

 

Alexandra Harrison

(020) 8047 5502

 

Jo Revill

(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