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FDA Declines to Fast-Track Glaxo Vaccine
Author: Health News31.05.2007
GlaxoSmithKline PLC revealed Thursday that the U.S. Food and Drug Administration has declined to grant a priority review to its experimental cancer vaccine Cervarix, adding to pressure on the drug maker after controversy surrounding its diabetes drug Avandia.
The FDA ruling means that Cervarix will have to go through a standard 10-month review, instead of a fast-track process that would have accelerated the approval and marketing of the vaccine in the key U.S. market.
Glaxo now expects to get the drug, which targets cervical cancer and is expected to become a multibillion-dollar product, to market in the United States sometime in 2008. Read more