
Acknowledgment of Class 2 Resubmission - Isoplate Solution


 

 

Our Reference: NDA BN090067

 

B. Braun Medical, Inc.

Attention: Susan Olinger, J.D.

901 Marcon Boulevard

Allentown, PA  18109

 

 

Dear Ms. Olinger:

 

We acknowledge receipt on November 10, 2011, of your November 7, 2011, resubmission of your new drug application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act, for Isoplate Solution in the 500 mL EXCEL Container.

 

We consider this a complete, class 2 response to our February 4, 2011, action letter. Therefore, the goal date is May 11, 2012.

 

If you have any questions, please call Iliana Valencia, Regulatory Project Manager, at (301) 827-6161.

 

Sincerely,

 

 

 /s/

Iliana Valencia

Acting Chief, RPM Branch

Division of Blood Applications         

 Office of Blood Research and Review 

Center for Biologics 

 Evaluation and Research