September 26, 2012 Approval Letter - Boostrix
Our STN: BL 125106/859
Attention: Mr. Michael VanDerWerf
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, Pennsylvania 19406-2272
Dear Mr. VanDerWerf:
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 a change in the Pregnancy Category designation in the package insert from
Category C to Category B.
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 CFR 202.1(e)(6)).
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