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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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,
 
 /s/
 
Raj K. Puri, M.D., Ph.D.
Director
Division of Cellular and Gene Therapies
Office of Cellular, Tissue, and Gene Therapies
Center for Biologics Evaluation and Research