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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 26, 2012 Approval Letter - Boostrix

 

Our STN:   BL 125106/859          
 
GlaxoSmithKline Biologicals  
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.
 
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 Draft Labeling