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Vaccines, Blood & Biologics
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 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
- Vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11
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Product Information
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Supporting Documents
- October 16, 2009 Approval Letter - Gardasil
- October 16, 2009 Approval - Gardasil - Clinical Review (PDF - 611KB)
Expanded indication of vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11. Persons with disabilities having problems accessing the PDF file may call 301-827-2000 for assistance. - October 16, 2009 Approval - Gardasil - Statistical Review (PDF - 202KB)
Expanded indication of vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11 - FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys
Press Release - 10/16/2009 - June 9, 2009 Approval Letter - Gardasil
- Reports of Health Concerns Following HPV Vaccination (CDC)
February 26, 2009 - September 12, 2008 Approval Letter - Gardasil
Prevention of vulvar and vaginal cancer. - FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Press Release - 9/12/2008 - Statistical Review and Evaluation - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
- Clinical Review - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 2584KB)
Prevention of vaginal and vulvar cancers related to HPV types 16 and 18... - Appendix 1 - VIN 2/3 and VaIN 2/3 Lesions - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 156KB)
- Appendix 2 - AIS Lesions - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 52KB)
- Appendix 3 - CIN 2 AND CIN 3 Cases Associated with Non-Vaccine HPV Types - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 96KB)
- 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... - Executive Summary - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 92KB)
- Gardasil (Human Papillomavirus Vaccine) Questions and Answers
- Clinical Review - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 4980KB)
- List of Tables - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 175KB)
- List of Figures - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 30KB)
- List of Appendices - Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (PDF - 262KB)
- FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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