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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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February 12, 2010 Approval Letter - Infanrix

Our STN:  BL 103647/5240

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 Vaccine Adsorbed, Infanrix®, 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,

---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