Glaxo CEO says will update FDA on Cervarix by Q3

Thu Feb 7, 2008 1:00pm GMT
 
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LONDON (Reuters) - GlaxoSmithKline (GSK.L) will update the U.S. Food and Drug Administration on its cervical cancer vaccine Cervarix by the third quarter of 2008, its chief executive said on Thursday.

"We are going to file a response to the FDA letter by the third quarter," Jean-Pierre Garnier told reporters in a post-results conference call, adding the U.S. agency was then likely to convene an advisory panel to consider the product.

Cervarix is viewed as a key new product for Glaxo but the FDA delayed its approval in December while it sought further information from the drugmaker.

Garnier said it was not possible to say whether Cervarix might yet get to market in the United States in 2008. Cervarix is already on sale in Europe.

(Reporting by Ben Hirschler)

 
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