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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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June 9, 2010 Approval Letter - Gardasil

Our STN:  BL 125126/1516

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 your biologics license application for Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, GARDASIL® for concomitant administration with Menactra® and ADACEL®.

The review of this product was associated with the following National Clinical Trial (NCT) number: 00325130.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide content of labeling in Structured Product Labeling format.

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,

/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

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Approved Final Draft Labeling

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