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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Letter - Novoeight

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our Reference:  STN BL 125466/0
 
Novo Nordisk, Inc.
Attention: Robert B. Clark
P.O. Box 846
Plainsboro, NJ 08536
 
Dear Mr. Clark:
 
We have reviewed your submission dated October 15, 2012 to your biologics license application (BLA) for Antihemophilic Factor (Recombinant), Plasma/Albumin Free, requesting a proprietary name review.
 
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, NOVOEIGHT, is acceptable at this time.
 
If you have any questions, please contact Leigh Pracht at (301) 827-6116.
 
Sincerely yours,
 
 /s/
 
Basil Golding, MD
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research