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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

April 10, 2012 Approval Letter - Fluzone

 

Our STN:   BL 103914/5529                    
 
Sanofi Pasteur Inc.
Attention: Mr. Joseph H. Quinn
Discovery Drive
Swiftwater, PA 18370
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine to include the additional syringe label design for Fluzone 0.25mL, Fluzone 0.5mL and Fluzone High-Dose syringe presentations with a detachable portion for patient records.
 
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.
 
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 the 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