DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
March 7, 2001
Jim C. Williams, Ph.D.
Aventis Pasteur, Inc.
Swiftwater, PA 18370-0187
Dear Dr. Williams:
The Supplement to your License Application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed (DTaP), Tripedia, to include a preservative-free, single dose vial presentation, has been approved.
Under this approval, lots of single dose preservative-free Tripedia shall have an expiration dating period of 18 months when stored at 2-8C. Any requests to extend the dating period beyond 18 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 submissions of February 9 and March 5, 2001, and in a telephone conversation held on February 22, 2001, between personnel from the Center for Biologics Evaluation and Research (CBER) and personnel from Aventis Pasteur Inc.
- Real time stability data on final containers for lots U0309A, U0310A and U0311A, will be accumulated at the following intervals: 6, 9, 12, 18, 24, and 36 months, and these stability data will be provided to CBER as they become available. In addition, you have agreed, in your letter of March 5, 2001, to submit stability data from your Bulk Vaccine program at the 9 and 12 month time points as soon as those data are made available.
- Validation studies on the manufacturing process for the Tripedia vaccine, to include the production of the diphtheria and tetanus toxoids and the formulation of the final product will be conducted. You have agreed, in your letter of March 5, 2001, to submit validation protocols regarding the manufacturing of the preservative-free Tripedia to CBER no later than April 2001, and that all validation studies will be completed no later than second quarter 2002. You have also agreed to submit status reports at six-month intervals describing the progress of the Tripedia preservative-free validation studies.
Please submit four copies of final printed labeling at the time of use and include the label transmittal form FDA 2567 (5/99) with completed implementation information.
This information will be included in your License Application file.
--- signature ---
Richard I. Walker, Ph.D.
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research