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Gardasil Approval History

Reviewed by J.Stewart BPharm Last updated on Apr 4, 2019.

FDA Approved: Yes (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Gardasil has now been replaced by Gardasil 9.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 History and FDA Approval Process for Gardasil

DateArticle
Dec 22, 2010Approval FDA: Gardasil Approved to Prevent Anal Cancer
Oct 16, 2009Approval FDA Approves Gardasil for Use in Boys and Young Men
Sep 15, 2008Approval FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Jun  8, 2006Approval FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases
May 18, 2006FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil
Feb  7, 2006Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration
Feb  2, 2006Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track
Dec  5, 2005Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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