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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 12, 2010 Approval Letter - Pediarix

Our STN: BL 103907/5389

GlaxoSmithKline Biologicals
Attention: Michael S. VanDerWerf
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Mr. VanDerWerf:

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 Combined, Pediarix®, to revise the Package Insert to add a warning regarding apnea in premature infants and to update the subsection on postmarketing adverse events.

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

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 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