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Gardasil 9 FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved December 10, 2014)
Brand name: Gardasil 9
Generic name: human papillomavirus 9-valent vaccine, recombinant
Dosage form: Injection
Company: Merck
Treatment for: Human Papillomavirus Prophylaxis

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) is a 9-valent HPV vaccine indicated for use in:

Gardasil (human papillomavirus quadrivalent vaccine, recombinant) was first approved June 8, 2006. The last doses of Gardasil expired on May 1, 2017 and it is no longer available for use in the United States. Gardasil has now been replaced by Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant).

Development timeline for Gardasil 9

Jun 15, 2020Approval FDA Approves Merck‚Äôs Gardasil 9 for the Prevention of Certain HPV-Related Head and Neck Cancers
Oct  5, 2018Approval FDA Approves Expanded Use of Gardasil 9 to Include Individuals 27 Through 45 Years Old
Dec 15, 2015Approval FDA Approves Expanded Age Indication for Gardasil 9 in Males
Dec 10, 2014Approval FDA Approves Gardasil 9 for Prevention of Certain Cancers Caused by Five Additional Types of HPV

Further information

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