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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

January 13, 2011 Approval Letter - Adacel

Our STN:   BL 125111/340

Sanofi Pasteur Limited
Attention:  Joseph H. Quinn
Discovery Drive, Swiftwater, PA 18370

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap),   to revise labeling to address latex hypersensitivity in the Precautions section of the package insert, and to correct the information regarding the tip caps of the prefilled syringes to state that they may contain natural rubber latex.  These labeling changes were made at CBER’s request since we have determined that information from the manufacturer of the tip caps is inadequate to support the claim that the tip caps do not contain latex.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h.  Please provide content of labeling in Structured Product Labeling format.  Please provide carton and container labeling in Structured Product Labeling format, as well as three original paper copies. 

We will include the 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 Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling