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Vaccines, Blood & Biologics

January 25, 2011 Approval Letter - Pediarix

Our STN: BL 103907/5474

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 Pediarix® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine, 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 a prefilled syringe that has a tip cap which may contain natural rubber latex. Labeling approved under STN 103907/5394 stated that the latter syringe did not contain latex. However, based on CBER's review of STN 103907/5422, we do not concur with the claim that these 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,

Wellington Sun, M.D.
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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