
Resubmission Acknowledgment Letter - Isoplate Solution


 
  
 

Our STN: NDA BN090067

 

 

B. Braun Medical, Inc.

Attention:  Ms. Rebecca Stolarick

901 Macron Boulevard

Allentown, PA 18109

 

Dear Ms. Stolarick

 

We acknowledge receipt on January 4, 2013, of your January 4, 2013, resubmission to your new drug application (NDA) submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Isoplate Solution, magnesium chloride USP 30mg/100mL.

 

We consider this a complete, class 1 response to our May 8, 2012, action letter. Therefore, the goal date is March 5, 2013.

 

If you have any questions, call Sonday L. Kelly, MS, RAC, Regulatory Project Manager, at (301) 827-6162.

 

Sincerely,

 

 /s/

 

Iliana Valencia, MS

Chief, Regulatory Project Management Branch

Division of Blood Applications

Office of Blood Research and Review

Center for Biologics

Evaluation and Research