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


 

 

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