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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Review Letter - Isoplate Solution

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

Our STN: NDA BN090067                                                                           
 
B. Braun Medical, Inc.          
Attention: Susan Olinger
901 Marcon Boulevard
Allentown, PA  18109
 
Dear Ms. Olinger:
 
We have reviewed your submission to your new drug application (NDA) dated June 13, 2010, for Isoplate Solution in the 500mL EXCEL container, requesting a proprietary name review.
 
In consultation with CBER’s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Isoplate Solution, is acceptable at this time.
 
We will perform another proprietary name review of Isoplate Solution closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
 
If you have any questions, please call Iliana Valencia, Regulatory Project Manager, at (301) 827-6161.
 
Sincerely,
 
 /s/
 
 Basil Golding, M.D.
 Director
Division of Hematology        
Office of Blood Research and Review
Center for Biologics
  Evaluation and Research