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July 15, 2011 Approval Letter - DAPTACEL
Our STN: BL 103666/5254
Sanofi Pasteur Limited
Attention: Joseph H. Quinn
1755 Steeles Avenue West
Canada M2R 3T4
Dear Mr. Quinn:
We have approved your request to supplement your biologics license application for Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (DAPTACEL®) to include changes to the package insert to update the safety data on use of a fifth dose of DAPTACEL® in children four through six years of age who received four doses of PENTACEL®.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. 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 [OPTION: 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
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 include these changes.
We will include 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 Vaccine
Research and Review
Center for Biologics
Evaluation and Research