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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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