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Gardasil Not Approved for Women Over 26

The Food and Drug Administration denied Merck and Co Inc’s application to expand Gardasil use to women over the age of 26 on Wednesday. The FDA cited pending issues with the vaccine that could not be researched during the review time-frame, according to Philadelphia Business Journal.

Gardasil is a human papillomavirus (HPV) vaccine that protects against about 70 percent of the HPV strains that are linked to cervical cancer. It was approved for use in girls and women between the ages of 9 and 26 in 2006.

The FDA also denied Merck’s proposal to expand the vaccine to cover other strains of the HPV. Merck and Co. is currently preparing to seek approval for use of the vaccine in men, according to CNN Money.

Sources:

Philadelphia Business Journal 6/25/2008; CNN Money 6/25/2008; Reuters 6/25/2008

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