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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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March 12, 2009 Approval Letter

Our STN: BL 103647/5196

GlaxoSmithKline Biologicals
Attention: Ms. Donna Boyce
2301 Renaissance Blvd, Bldg 510
King of Prussia, PA 19406-2772

Dear Ms. Boyce:

We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, (INFANRIX), to revise the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX and updated safety and immunogenicity data on the concomitant administration of INFANRIX with other recommended vaccines.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.

We will include 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