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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 12, 2008 Approval Letter - Gardasil

September 12, 2008

Our STN: BL 125126/419

Merck & Co., Inc.
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 to your biologics license application (BLA) to include efficacy data on duration of protection, with an expansion of indication to include prevention of vulvar and vaginal cancer and an updated PI to comply with PLR format.

All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens must contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We are deferring submission of your pediatric studies for patients under 9-years of age for this application because pediatric studies should be delayed until additional safety or effectiveness data have been collected.

Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert and printed in a minimum of 10-point font.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

In addition, you may wish to submit 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, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253. 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 to support that claim.

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

Sincerely yours,

/Wellington Sun/

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

 

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