Licensed vaccine
Gardasil
FDA-licensed vaccine · Merck & Co., Inc 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 · STN 125126
Key facts
| Trade name | Gardasil |
|---|---|
| Proper name | Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant |
| Manufacturer | Merck & Co., Inc 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 |
| Submission tracking number (STN) | 125126 |
| FDA product areas | Biologics, Vaccines |
| Recent FDA documents | Approval History, Letters, Reviews, and Related Documents - Gardasil, Patient Information about Gardasil, Package Insert - Gardasil, Supporting Documents older than three years - Gardasil |
| FDA page updated | Mar 6, 2023 |
| FDA product page | fda.gov |
At a glance
- None FDA approval letters
- 1–9 Supporting documents
- 1–9 Product information documents
- Yes Document full text searchable in Orca1
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-licensed vaccines
The FDA's CBER licenses vaccines for use in the United States. Each product page links the approval letters, package inserts and supporting documents for that vaccine.
Source: U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Vaccines Licensed for Use in the United States · Source date: