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Vaccines, Blood & Biologics

July 7, 2003 Approval Letter - Infanrix

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

July 7, 2003

Submission Tracking Number (STN): BL 103647/5001

Johan Van Hoof, M.D.
GlaxoSmithKline Biologicals
89, Rue de l'Institut
B-1330 Rixensart

Dear Dr. Van Hoof:

The Supplement to your Biologics License Application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (Infanrix), to include in the indication a fifth dose at 4-6 years of age after 4 prior doses of Infanrix, has been approved.

We acknowledge the following clinical commitment made in your letter of May 16, 2003 as follows:

You have agreed to submit results for ongoing Study 213503/047, to obtain additional safety data on a fifth dose of Infanrix in children 4-6 years of age who have previously received four doses of Infanrix. The protocol for Study 213503/047 was submitted to BB-IND ------ in September 2002, and the study was initiated in October 2002. The study will be completed (last patient exited) by October 31, 2004, and the final study clinical report will be submitted to FDA by January 31, 2005.

Please submit four copies of final printed labeling at the time of use and include Form FDA 2567 (09/02) with completed implementation information. In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with a Form FDA 2567 or Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. Final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a Form FDA 2567 or Form FDA 2253.

All promotional claims must be consistent with and not 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.

This information will be placed in your biologics license application file for this product.

Sincerely yours,

--- signature ---

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

Attachment: Approved Package insert labeling form 2567

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