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January 16, 2009 Approval Letter - Adacel

January 16, 2009

Our STN BL 125111/193

Attn: Gary K. Chikami, M.D.

Sanofi Pasteur, Inc.

Discovery Drive

Swiftwater, PA 18370

Dear Dr. Chikami:

We have approved your request to supplement your biologics license application for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Adacel®) to revise the package insert to include revision of the placement of information regarding latex content of the product.

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).

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, MD


Division of Vaccines and Related

Products Applications

Office of Vaccines

Research and Review

Center for Biologics

Evaluation and Research

Attachment: Approved Final Draft Labeling