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Issued: Tuesday 29 September 2009

GlaxoSmithKline (NYSE: GSK) announced today the U.S. Food and Drug Administration (FDA) has not yet completed the review of the Biologics License Application (BLA) for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant], the Company’s candidate cervical cancer vaccine.  As a result of this, the review will continue beyond the September 29, 2009, action date.

GSK remains confident in the BLA submission and expects the FDA to complete their review soon.  

The BLA was submitted to the FDA in March 2009.

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

 

Gwenan White

(020) 8047 5502

 

 

 

US Media enquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Lisa Behrens

(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

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