Merck announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee “has advised that the data presented support an indication for GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer and anal intraepithelial neoplasia (AIN) in both males and females 9 through 26 years of age.” The Committee’s input will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in early 2010. The FDA is not bound by the Committee’s guidance, but takes its advice into consideration when reviewing vaccines.

http://www.businesswire.com/news/home/20101117006740/en/FDA-Advisory-Committee-Supports-Approval-GARDASIL%C2%AE-Prevention