Product Approval Information - Licensing Action
March 18, 2008
Our STN BL 125111/102
Sanofi Pasteur Limited
Attn: Gary K. Chikami, M.D.
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
CANADA
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 include unit dose syringes as an alternate presentation.
Under this approval, the expiration date for the unit dose syringe presentation of ADACEL® will be 30 months when stored at 2-8oC. Any requests to extend the dating period beyond 30 months will require the submission of a prior approval supplement containing supporting data to your biologics license application.
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.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
/Milan S. Blake, Ph.D./
Milan S. Blake, Ph.D.
Acting Director
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling