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December 22, 2010 Approval Letter - Gardasil

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448

December 22, 2010

Our STN: BL 125126/1895

Merck Sharp & Dohme Corp.
Attention: Patrick Brill-Edwards, M.D.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099

Dear Dr. Brill-Edwards:

We have approved your request to supplement your biologics license application for Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, GARDASIL®, to include the prevention of anal intraepithelial neoplasia (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 the prevention of anal cancer caused by HPV types 16 and 18 in males and females 9 through 26 years of age.
The review of this product was associated with the following National Clinical Trial (NCT) number: 00090285.

Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10-point font.

Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/UCM072392.pdf
.

You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.

Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.

We are waiving the pediatric study requirement for ages 0 through 8 years because the product does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this age group and is not likely to be used in a substantial number of pediatric patients in this group because evidence indicates that the rare cases of HPV-related disease that occur in this age group are not vaccine-preventable.

We note that you have fulfilled the pediatric study requirement for ages 9 through 17 years for this application.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/signature/

Wellington Sun, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccine Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling