DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research