Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

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

Page Last Updated: 09/24/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English