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Vaccines, Blood & Biologics

June 5, 2008 Approval Letter - TENIVAC

June 5, 2008

Our STN: BL 103171/5045

Sanofi Pasteur Limited
Attention: Gary Chikami, M.D.
1755 Steeles Avenue West
Toronto, ON Canada M2R 3T4

Dear Dr. Chikami:

We have approved your request to supplement your biologics license application for Tetanus and Diphtheria Toxoids Adsorbed (TENIVAC™) to include use in adults 60 years of age and older for active immunization for the prevention of tetanus and diphtheria.

This fulfills your commitment to conduct a safety and immunogenicity post-marketing study in approximately 3,000 subjects receiving TENIVAC, to include a subset of subjects 60 years of age and older as stated in commitment #1 of the November 3, 2003, approval letter.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.

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

Sincerely yours,

/Loris D. McVittie/

Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and
    Related Product Applications
Office of Vaccines
    Research and Review
Center for Biologics
   Evaluation and Research

Attachment: Approved Draft Labeling

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