Product Approval Information
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