Glaxo's Cervarix delayed until late 2009

Call it a tale of two countries: Last week, the U.K. tapped GlaxoSmithKline's Cervarix as its preferred HPV vaccine, clearing the way for the National Health Service to put it on every young British girl's shot program. But in the U.S., the vaccine probably won't be OK'd for sale until late 2009.

Glaxo announced today that it handed over some Cervarix info to the FDA as the agency requested, but it has decided to augment its approval app with final data from a Phase III study. That data won't be ready until early next year, and review is expected to take some six months more. So the earliest date Cervarix might reach the U.S. market is more than a year away.

- read GSK's release

ALSO: In the wake of worries about Pfizer's Chantix stop-smoking med, GSK plans to step up advertising of its smoking cessation products. Report

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