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This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

GlaxoSmithKline Update on FDA Review of Cervarix

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 us.gsk.com

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US Media Inquiries:

Nancy Pekarek

(919) 483 2839

 

Mary Anne Rhyne

(919) 483 2839

 

Kevin Colgan

(919) 483 2839

 

Sarah Alspach

(919) 483 2839

               

 

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2008.

 

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Updated 30 September 2009
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