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March 24, 2004 Approval Letter - DECAVAC
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville MD 20852-1448
March 24, 2004
Submission Tracking Number (STN): BL 103921/5031
Luc Kuykens, MD, DTM, MPH
Aventis Pasteur Inc
Swiftwater, PA 18370
Dear Dr. Kuykens:
The Supplement to your Biologics License Application for Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use, to include the addition of a preservative-free, single dose Luer-Lok syringe presentation has been approved.
Under this approval, lots of single dose preservative-free Td Adsorbed shall have an expiration dating period of 24 months when stored at 2-80 C. 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 have considered your proposed proprietary name DECAVAC in consultation with CBER's Advertising and Promotional Labeling Branch, and we conclude that under 21 CFR Part 201, the proposed proprietary name is acceptable.
We acknowledge the following commitments outlined in your submission dated March 16, 2004.
- You have agreed to accumulate real time stability data on final containers for lots --------, ------, and ------- at the following intervals: 6, 9, 12, 18, 24, --------------- months. These stability data will be submitted to CBER for review as they become available. In addition, you have agreed to submit real time stability data on the final formulated bulk vaccine for lots -----, -----, and ----- at intervals of ---------- months as they become available.
- You have agreed to accumulate real time stability data on Diphtheria Toxoid, Preservative Free, Adsorbed batches -------------, -------, and ------ at the -- month interval and submit these data to CBER for review.
Please submit four copies of final printed labeling at the time of use with completed implementation information.
This information will be included in your License Application file.
Richard I. Walker, Ph.D.
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research