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http://www.fda.gov/cber/approvltr/diphave012903L.htm
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
January 29, 2003
Submission Tracking Number (STN): BL 103919/5018
Luc Kuykens, M.D.
Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
Dear Dr. Kuykens:
The Supplement to your Biologics License Application for Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use, to include addition of a preservative-free, single dose vial presentation has been approved.
Under this approval, lots of single dose preservative-free DT Adsorbed shall have an expiration dating period of 24 months when stored at 2-8 0C. Any requests to extend the dating period beyond 24 months will require the submission of supporting data as a Supplement to your License Application for review and approval.
We acknowledge the following commitments outlined in your letter dated January 21, 2003:
Please submit four copies of final printed labeling at the time of use and include the label transmittal form FDA 2567 (6/01) with completed implementation information.
This information will be included in your License Application file.
Sincerely yours,
--- signature ---
Richard I. Walker, Ph.D.
Director
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Last Updated: 3/25/2003
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