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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.
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.
-- signature --
Wellington Sun, MD
Division of Vaccines and Related
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling