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Vaccines, Blood & Biologics

March 5, 2010 Approval Letter - Pediarix

Our STN: 103907/5227
GlaxoSmithKline Biologicals
Attention: Ms. Elysia Tusavitz
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Tusavitz:

We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine, Pediarix®, to include in the package insert, the results from a postmarketing safety surveillance study that evaluated the risk of all seizures (with or without fever), and the risk of medically attended fever following Pediarix® administration in a cohort of infants at a United States Health Maintenance Organization, and to comply with the labeling requirements of the Physician’s Labeling Rule.

This fulfills your commitment to conduct a post marketing study to evaluate the risk of seizures and medically attended fever following Pediarix® administration, as stated in commitment number three of the December 13, 2002, approval letter.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format.

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims [21 CFR 202.1(e)(6)].

We will include information contained in the above-referenced supplement in your biologics license application files.

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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