Product Approval Information
Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Tradename: Gardasil
Manufacturer: Merck & Co., Inc, License #0002
Package Insert (PDF - 206 KB) - Approved: January 9, 2008
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Date: June 8, 2006
Indication: Vaccination in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:
- Cervical cancer
- Genital warts (condyloma acuminata)
and the following precancerous or dysplastic lesions: - Cervical adenocarcinoma in situ (AIS)
- Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
- Cervical intraepithelial neoplasia (CIN) grade 1
June 8, 2006 Approval Letter
Executive Summary (PDF - 92 KB)
Questions and Answers
FDA Consumer: New Vaccine Prevents Cervical Cancer
FDA News Release
Get the Facts: HPV (human papillomavirus) - FDA's Office of Women's Health