Merck Submits Final Data For Application To Market HPV Vaccine Gardasil To Older Women
Main Category: Cervical Cancer / HPV VaccineAlso Included In: Women's Health / Gynecology; Regulatory Affairs / Drug Approvals
Article Date: 15 Jan 2010 - 4:00 PDT
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Merck on Wednesday announced that it has provided FDA with completed trial data on its human papillomavirus vaccine, Gardasil, in support of its application to market the vaccine to women ages 27 through 45, Reuters reports. FDA in 2006 approved Gardasil for girls and women ages nine through 26 to protect against certain strains of HPV that can lead to cervical cancer and genital warts.
In early 2008, FDA denied approval of the vaccine for use in older women and asked the drugmaker to submit more data after the completion of a 48-month trial. Merck said it provided the additional data at the end of 2009. The agency typically takes about six months to review such submissions, according to Reuters (Pierson, Reuters, 1/13).
Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
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MLA
13 Feb. 2012. <http://www.medicalnewstoday.com/releases/176125.php>
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http://www.medicalnewstoday.com/releases/176125.php.
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