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

Proprietary Name Review Letter, March 1, 2013 - ALLOCORD

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service

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


Our STN: 125413/0                                                                           March 1, 2013                       
SSM Cardinal Glennon Children's Medical Center
Attention: Ms. Donna M. Regan
3662 Park Avenue
St. Louis, MO 63110
Dear Ms. Regan:
We have reviewed your submission dated December 3, 2012 to your biologics license application (BLA) for HPC, Cord Blood 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, ALLOCORD, is acceptable at this time. Please note that the utilization of tallman lettering, i.e., AlloCORD, is not recommended.
We will perform another proprietary name review of ALLOCORD closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
If you have any questions, please contact the Regulatory Project Manager, Lori A. Tull, at (301) 827-5359.
Sincerely yours,
Raj K. Puri, M.D., Ph.D.
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research

Page Last Updated: 06/26/2013
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