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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 29, 2005 Approval Letter - Boostrix

December 29, 2005

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