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Gardasil 9 Approval History

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

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:

  • girls and women 9 through 45 years of age for the prevention of:
    • cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
  • boys and men 9 through 45 years for the prevention of:
    • anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58
    • genital warts (condyloma acuminata) caused by HPV types 6 and 11
    • precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

Development History and FDA Approval Process for Gardasil 9

DateArticle
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.

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