FDA Drug Approvals
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FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases

Gardasil is a recombinant vaccine indicated for the prevention of cervical cancer, cervical pre-cancers, vulvar pre-cancers and vaginal pre-cancers caused by HPV types 16 and 18. Gardasil is also approved for the prevention of genital warts and low-grade cervical lesions caused by HPV types 6, 11, 16 and 18. Gardasil is approved for 9- to 26-year-old girls and women.

Related Articles:

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers - September 15, 2008

FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil - May 18, 2006

Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration - February 7, 2006

Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track - February 2, 2006

Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer - December 5, 2005

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