Proprietary Name Review Letter, November 16 2012 - Novoeight
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
Our Reference: STN 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 16, 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.
We will perform another proprietary name review of NovoEight closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
If you have any questions, please contact Leigh Pracht at (301) 827-6116.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research