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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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December 1, 2010 Approval Letter - Boostrix

Our STN:   BL 125106/469
GlaxoSmithKline Biologicals
Attention:  Donna Boyce
2301 Renaissance Boulevard, Building 510
King of Prussia, PA 19406-2272

Dear Ms. Boyce:

We have approved your request to supplement your biologics license application for Boostrix® (Tetanus Toxoids, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed), to revise labeling to address latex hypersensitivity in the Warnings and Precautions section of the package insert; to include a presentation in a prefilled syringe with components that contain dry natural latex rubber; and to correct the information regarding latex for the other prefilled syringe that has a tip cap which may contain natural rubber latex and minor editorial updates.  Your initial submission claimed the replacement syringe component did not contain latex, but based on CBER’s review of STN 125106/612, we do not concur with the proposed latex claim.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h.  Please provide content of labeling in Structured Product Labeling format.  Please provide carton and container labeling in Structured Product Labeling format, as well as three original paper copies. 

We will include the information contained in the above referenced supplement in your Biologics License Application file.

Sincerely yours,

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling

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Approved Final Draft Labeling

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