Vaccines, Blood & Biologics
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Gardasil
Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Tradename: Gardasil
Manufacturer: Merck & Co., Inc, License #0002
Indications:
- Prevention of vulvar and vaginal cancer
- Vaccination in females 9 through 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
- Vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11
- Vaccination in people ages 9 through 26 years for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18
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Supporting Documents
Clinical Review of BLA Supplement - Mid-Adult Women Indication - Gardasil (PDF - 377KB)Summary Basis for Regulatory Action - Gardasil, August 25, 2010 (PDF - 125KB)April 5, 2011 Approval Letter - Gardasil
To include information on women 27 through 45 years of age in the Package Insert.- December 22, 2010 Approval Letter - Gardasil
Includes the prevention of (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine, in males and females 9 through 26 years of age, and prevention of anal cancer caused by HPV types 16 and 18 in males and females 9 through 26 years of age. Statistical Review and Evaluation, Anal Cancer - Gardasil, August 30, 2010 (PDF - 1.2MB)
The following document has been updated and reposted. Please disregard the previously posted version.Clinical Review BLA Supplement - Anal Cancer Indication - Gardasil (PDF - 454KB)Summary Basis for Regulatory Action - Gardasil, December 3, 2010 June 9, 2010 Approval Letter - Gardasil
Concomitant administration with Menactra® and ADACEL®.October 16, 2009 Approval Letter - Gardasil June 9, 2009 Approval Letter - Gardasil September 12, 2008 Approval Letter - Gardasil
Prevention of vulvar and vaginal cancer.June 12, 2008 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
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...June 8, 2006 Approval Letter - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
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...Gardasil (Human Papillomavirus Vaccine) Questions and Answers - Gardasil, June 8, 2006 Summary Basis for Regulatory Action - Gardasil, June 9, 2010 (PDF - 69KB)Approval History, Letters, Reviews, and Related Documents - Gardasil Information Pertaining to Labeling Revision for Gardasil
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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