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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Letter, March 22, 2013 - HPC, Cord Blood BLA 125432

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

Our STN: BL 125432/0                                                                     
 
 
LifeSouth Community Blood Centers, Inc.
Attention: Nancy Eckert
4039 Newberry Road
Gainesville, FL 32607
 
 
Dear Ms. Eckert:
 
We have reviewed your submission dated February 1, 2013 to your biologics license application (BLA) for Hematopoietic Progenitor Cells, Cord Blood (HPC-C) 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 name, --(b)(4)--, is unacceptable. 
 
The proposed proprietary name is considered misleading and/or fanciful.
 
The basis for our decision is:
 
The name is the combination of the --------------------(b)(4)-----------------------------------------, with the meaning of lifesaving cells or cells providing life, misleadingly implies that the product has a survival effectiveness beyond that supported by the data.
 
You may submit a new proprietary name for FDA consideration. Any alternate proprietary name(s) should comply with the regulations regarding false, misleading or fanciful names and should not be confused with other medicinal products with orthographic or phonological similarities.
 

If you have any questions, please contact Candace Jarvis at (301) 827-5357.

 
Sincerely yours,
 
 
 
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