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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

PNR Accepted - Flucelvax

 

Our STN: 125408/0                                                                          
 
Novartis Vaccines and Diagnostics, Inc.
Attention: Matthew Gollwitzer
350 Massachusetts Avenue
Cambridge, MA 02139
                         
Dear Mr. Gollwitzer:
 
We have reviewed your submission dated June 28, 2012, to your biologics license application (BLA) for Influenza Vaccine (MDCK Cells) requesting a proprietary name review. 
 
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB), we conclude that your proposed proprietary name, Flucelvax, is acceptable under the Federal Food, Drug, and Cosmetic Act and applicable regulations. Your alternate proposed proprietary name,      --(b)(4)--, is unacceptable because of the potential medication errors with penicillin antibiotics.
 
If you have any questions, please contact Dr. Brenda Baldwin or Dr. Timothy Fritz at (301) 796-2640.
 
 
Sincerely yours,
 
 
 
Wellington Sun, M.D.
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccine
 Research and Review
Center for Biologics
Evaluation and Research