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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Acknowledgment of Class 2 Resubmission - Isoplate Solution

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


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

 

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