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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
 
