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 - 464 KB) - Approved: September 12, 2008
Patient Information about GARDASIL (PDF - 41 KB)

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Date: September 12, 2008
Additional Indication: Prevention of vulvar and vaginal cancer
September 12, 2008 Approval Letter
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers - 9/12/2008
Statistical Review and Evaluation

Information from CDC and FDA on the Safety of Gardasil Vaccine - 7/14/2008

Date: June 12, 2008
Changes to the package insert: To include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert
June 12, 2008 Approval Letter

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

Clinial Review (PDF - 4.9 MB)

FDA Consumer: New Vaccine Prevents Cervical Cancer
FDA News Release
Get the Facts: HPV (human papillomavirus) - FDA's Office of Women's Health

Updated: September 18, 2008