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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 25, 2013 Approval Letter - TENIVAC

 

Our STN:   BLS 103171/5113
 
Sanofi Pasteur Limited
Attention: Mr. Joseph H. Quinn
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
 
 
Dear Mr. Quinn:
 
We have approved your request to supplement to your biologics license application for
Tetanus and Diphtheria Toxoids Adsorbed, TENIVAC ® to include the addition of the NDC to your detachable 2D barcode vial & syringe labels, vial and syringe carton labels, the addition of the new Sanofi Pasteur logo to your carton labels and package insert, and to add the new logo and the NDCs for all labels in the “How Supplied” section of the package insert.
 
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.
 
 
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