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Vaccines, Blood & Biologics
February 13, 2013 Approval Letter - Boostrix
Our STN: BL 125106/849
GlaxoSmithKline Biologicals, S.A.
Attention: Ms. Donna Boyce
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, Pennsylvania 19406-2272
Dear Ms. Boyce:
We have approved your request to supplement your biologics license application for
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Boostrix®
, to include changes to the Full Prescribing Information to update the Postmarketing Experience section.
Please provide your final content of labeling in Structured Product Labeling (SPL). All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
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
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research