
Proprietary Name Review Letter - Isoplate Solution


 
 

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