Vaccines, Blood & Biologics

June 30, 2011 Approval Letter - FluMist 2011/2012 Forumation

Our STN:  BL 125020/1670                    

 
MedImmune, LLC
Attention: Nancy R. Kavanaugh, Ph.D.
One MedImmune Way
Gaithersburg, MD 20878
 
Dear Dr. Kavanaugh:
 
We have approved your request to supplement your biologics license application for Influenza Vaccine Live, Intranasal (FluMist®), 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 note that the FluMist package insert was approved under STN 125020/1465.
 
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
 

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