Vaccines, Blood & Biologics
Resources for You
June 9, 2010 Approval Letter - Gardasil
Our STN: BL 125126/1516
Merck & Co., Inc.
Attention: Patrick Brill-Edwards, M.D.
P.O. Box 1000
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.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling