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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 8, 2011 Approval Letter - Boostrix

Our STN: BL 125106/680        

 
GlaxoSmithKline Biologicals
Attention: Michael VanDerWerf
2301 Renaissance Blvd
King of Prussia, PA
 
Dear Michael 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 immunogenicity and safety data to support the use of Boostrix® in individuals 65 years of age and older.
 
The review of this product was associated with the following National Clinical Trial numbers: 00835237 and 00385255.
 
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling.  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 and FDA Form 2567 as appropriate.
 
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
.
 
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
 
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 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