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news.The US Food and Drug Administration (FDA) has approved new indication for Merck's Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of cancer caused due by human papillomavirus (HPV) and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3.
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The FDA approval of Gardasil applies for prevention of anal cancer caused by HPV types 16 and 18, and for the prevention of AIN caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.
Gardasil was approved in the US for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18, genital warts caused by HPV types 6 and 11, and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.
In addition, Gardasil was approved in the US for use in boys and men ages 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11.
Merck Research Laboratories executive director Richard Haupt said the company is pleased that with this new indication for GARDASIL against HPV-related anal cancer and disease, both males and females can be protected against cancer, which further reinforces the importance of vaccinating both genders.