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DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20852-1448 December 29, 2005 Our Submission Tracking Number (STN): BL 125106/10 GlaxoSmithKline Biologicals Attn: Ms. Donna Boyce 2301 Renaissance Boulevard Building 510, P.O. Box 61540 King of Prussia, PA 19406-2772 Dear Ms. Boyce: We have approved your request to supplement your biologics license application for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, to include addition of clinical safety information to the package insert. We will include information contained in the above-referenced supplement in your biologics license application file. Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as one original paper copy. 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

Updated December 30, 2005

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