
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

 