Proprietary Name Review Letter - Eloctate

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

 

 

Our STN:  BL 125487/0

Biogen Idec Inc.
Attention:  Nadine D. Cohen, PhD
14 Cambridge Center
Cambridge, MA  02142

Dear Dr. Cohen:

We have reviewed your submission dated May 1, 2013 to your biologics license application (BLA) for Antihemophilic Factor (Recombinant), Fc Fusion protein, 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, ELOCTATE, is acceptable at this time.

We will perform another proprietary name review of ELOCTATE 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.

Sincerely yours,

 

Basil Golding, MD
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research