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October 9, 2013 Approval Letter - TheraCys

 

Our STN: BL 103943/5206        
 
Sanofi Pasteur  
Attention: Joseph H. Quinn
1755 Steeles Avenue
West Toronto, Ontario M2R 3T4
Canada
 
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application for TheraCys®   to assign a new NDC code, to modify the container label to assign a 2d Data matrix and encode for lot number and expiry date, and to modify the carton labels and USPI with a new 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.
 
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,
 
Raj K. Puri, M.D., Ph.D.
Director
Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research
   
 
 
 Enclosure: Package Insert