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

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.

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