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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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June 30, 2011 Approval Letter - Fluvirin 2011/2012 Formulation

Our STN:   BL 103837/5571                    

 
Novartis Vaccines and Diagnostics Limited
Attention: Dr. Joanne Totosy de Zepetnek, PhD
350 Massachusetts Avenue
Cambridge, MA 02139-4182
 
Dear Dr. Totosy de Zepetnek:
 
We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, (Fluvirin®), to include the 2011-2012 United States formulation.
 
Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels.  
 
We will include information contained in the above-referenced supplement in your Biologics License Application file.
 
Sincerely yours,
 
Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research
 
Attachment: Approved Final Draft Labeling