Gardasil FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
FDA Approved: Yes (Discontinued) (First approved June 8, 2006)
Brand name: Gardasil
Generic name: human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant
Dosage form: Injection
Company: Merck & Co., Inc.
Treatment for: Human Papillomavirus Prophylaxis
Marketing Status: Discontinued
Gardasil has now been replaced by Gardasil 9.
The last doses of Gardasil (quadrivalent) expired on May 1, 2017 and it is no longer available for use in the United States.
Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated in girls and women 9 through 26 years of age for the prevention of:
- cervical, vulvar, vaginal, and anal cancers caused by human papillomavirus (HPV) types 16 and 18
- genital warts (condyloma acuminata) caused by HPV types 6 and 11
- precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18
Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of:
- anal cancer caused by HPV types 16 and 18
- genital warts (condyloma acuminata) caused by HPV types 6 and 11
- precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18
In December 2014, the FDA announced the approval of Gardasil 9 for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. Gardasil 9 adds protection against five additional HPV types - 31, 33, 45, 52 and 58 - which cause approximately 20 percent of cervical cancers.
Development timeline for Gardasil
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
