Vaccines, Blood & Biologics
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May 29, 2013 Approval Letter - TENIVAC
Our STNs: BLS 125145/260, 103666/5310, 125111/492 & 103171/5105
Sanofi Pasteur Limited
Attention: Joseph H. Quinn
Swiftwater, PA 18370
Dear Mr. Quinn:
We have approved your requests to supplement to your biologics license applications for Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated - Pentacel®, Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed - DAPTACEL®, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed - Adacel®, and Tetanus and Diphtheria Toxoids Adsorbed- TENIVAC® to include the addition of an expiration date "(E)" on the detachable portion of the vial label.
Under 21 CFR 610.60(a) (4), the expiration date should be printed on the container label. We request that the text of information distributed to patients be printed in a minimum of 10-point font.
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.
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)).
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 Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling