• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Proprietary Name Review Letter - SOLX® System

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

Our Reference: BN110059/0                                                                         

Hemerus Medical, LLC
Attention: Ms. Lynn Jensen
5000 Township Parkway
Saint Paul, MN  55110

Dear Ms. Jensen:

We have reviewed your submission dated December 12, 2011 to your new drug application (NDA) for HEMERUS LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive 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, SOLX® System, is acceptable at this time.

We will perform another proprietary name review of SOLX® System closer to the time of action due date to ensure we have not approved a product with a conflicting proprietary name in the interim.

If you have any questions, please contact Sonday L. Kelly at (240) 507-8446.

Sincerely yours,

/s/

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