Glaxo's Cervarix vaccine gets standard FDA review

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LONDON | Thu May 31, 2007 2:57am EDT

LONDON May 31 (Reuters) - GlaxoSmithKline Plc's (GSK.L) new cervical cancer vaccine Cervarix will get a standard 10-month review from the U.S. Food and Drug Administration, rather than a rapid one that could have been completed in just six months.

A company spokesman said on Thursday the U.S. agency had declined to grant the accelerated review.

Glaxo had said previously there was a chance of a priority review, which might have got Cervarix to market in the United States this year, but hopes were never that high.

Tim Anderson of Prudential Equity said in a note it now looked likely Merck & Co. Inc.'s (MRK.N) rival product Gardasil, which is already on the market, would not have a competitor in the United States until the first quarter of 2008.

Cervarix is expected to go on sale earlier in Europe, where it could win a positive recommendation from the European Medicines Agency next month.

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