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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.
 
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
 
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.
 
 
 
 
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