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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

February 22, 2013 Approval Letter- TUBERSOL

Our STN:  BL 103941/5123      

 
Sanofi Pasteur Limited
Attention:  Joseph H. Quinn
1755 Steeles Avenue West
Toronto, Ontario
Canada M2R 3T4
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application for Tuberculin, Purified Protein Derivative, TUBERSOL®, to revise the package insert to include two additional adverse events from post-marketing experience and other minor changes and to revise the carton and container labeling to include a 2D barcode and a revised company logo.
 
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)).
 
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.
                                                                        Division 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