
Requesting a Proprietary Name Review Letter - Octaplas

 

 
DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

Our STN: 125416/0                                                             

 

Octapharma Pharmazeutika Produktionsges.m.b.H.

Attention: Mr. Stanley Ammons

Octapharma USA, Inc.

121 River Street, 12th floor

Hoboken, NJ  07030

                          

Dear Mr. Ammons:

 

We have reviewed your submission dated July 10, 2012 to your biologics license application (BLA) for Pooled Plasma (Human), Solvent/Detergent Treated, 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, Octaplas, is acceptable at this time.

 

If you have any questions, please contact Pratibha Rana at (301) 827-6124.

 

Sincerely yours,

 

 /s/

 

 Basil Golding, M.D.

Director

Division of Hematology

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research

 