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Vaccines, Blood & Biologics

August 26, 2010 Approval Letter - Infanrix

Our STN: BL 103647/5234

GlaxoSmithKline Biologicals
Attention: Michael S. VanDerWerf
2301 Renaissance Boulevard, Building 510
King of Prussia, PA 19406-2272

Dear Mr. VanDerWerf:

We have approved your request to supplement your biologics license application for Infanrix® Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed, to include a presentation in a prefilled syringe which has a tip cap which may contain natural rubber latex and plunger which does not contain latex. Based on CBER’s review of STN 103907/5422, we do not concur with your initially proposed claim that the new syringes do not contain latex.

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,

/signature/

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

Approved Final Draft Labeling

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