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August 24, 2000 Approval Letter - Tripedia

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

August 24, 2000

Jim C. Williams, Ph.D.
Aventis Pasteur, Inc.
Discovery Drive
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 in the indication a 5th dose at 4-6 years of age after 4 prior doses of Tripedia, submitted under section 351 of the Public Health Service Act, has been approved.

We acknowledge the following commitment made in your submission dated August 16, 2000:

You have agreed to perform a post-marketing study in at least 1500 children to obtain additional safety data on a fifth dose of Tripedia in children 4-6 years of age who have received four previous doses of Tripedia. You have agreed to submit the study protocol [-------] by September 30, 2000 for our review.

Please submit three copies of all final printed labeling under label review number 20000524001 and include the label transmittal form FDA 2567 (5/99) with completed implementation information. In addition, please submit three copies of the introductory advertising and promotional labeling that you plan to use to announce this new dosage schedule. You may wish to submit the proposed materials in draft using FDA form 2567 to the Center for Biologics Evaluation and Research, Advertisement and Promotional Labeling Staff, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Two copies of final advertising and promotional materials should be submitted at the time of use with FDA form 2567 to the Advertisement and Promotional Labeling Staff. Please include copies of the approved labeling (package insert) with your advertising and promotional materials. Promotional claims should not be contrary to approved labeling.

No comparative claims or claims of superiority over other similar products should be made unless data to support such claims are submitted to and approved by CBER.

Sincerely yours,

--- signature ---

Karen L. Goldenthal, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research