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Merck Fails to Win FDA Approval on Gardasil Use in Older Women

April 07, 2011
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Bloomberg reports that Merck & Co. has failed to win U.S. approval to expand use of the cervical-cancer vaccine Gardasil to older women. The FDA didn’t grant the company’s application to market the drug to women ages 27 to 45. Gardasil is designed to prevent human papillomavirus infections, which can cause cervical cancer and genital warts. The vaccine won FDA approval in 2006 for use in female patients ages 9 to 26, and was cleared for males in that age group in 2009. The treatment generated $988 million in 2010, a decrease of 12 percent from 2009, according to company filings. The FDA in 2008 granted a six-month expedited review of Merck’s application to expand Gardasil’s use to older women. The agency delayed its decision three times as it sought more information from the company.

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