Vaccines, Blood & Biologics
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.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research