Proprietary Name Review Acceptance Letter - ALPROLIX

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

 

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


Our STN:  BL 125444/0    

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

Dear Dr. Cohen:

We received your request for a proprietary name review on January 11, 2013, as amendment 2 to your biologics license application (BLA) for Coagulation Factor IX (Recombinant), Fc Fusion Protein. 

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, ALPROLIX™, is acceptable at this time.

We will perform another proprietary name review of ALPROLIX™ within 90 days of the action due date to determine if additional products with proprietary names similar in spelling or pronunciation to ALPROLIX™ have been approved.

If you have any questions, please contact Edward M. Thompson at (301) 827-9167.

Sincerely yours,

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