
Biologics license application (BLA) Amendment Letter - Octaplas


  
 

Our STN: BL 125416/0

 

Octapharma Pharmazeutika Produktionsges.m.b.H.

Attention: Mr. Stanley Ammons

Octapharma USA, Inc.

121 River Street, 12th floor

Hoboken, NJ  07030

 

Dear Mr. Ammons:

 

We received your August 13, 2012 amendment to your biologics license application (BLA), submitted under section 351 of the Public Health Service Act (42 U.S.C. 262), for Pooled Plasma (Human), Solvent/Detergent Treated, on August 13, 2012.

 

We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Safety and Innovation Act of 2012 and will add an additional three months to the time by which we should complete our review. 

Therefore, the action due date is January 21, 2013.

 

If you have any questions, please contact the Regulatory Project Manager, Pratibha Rana, at (301) 827-6124.

 

Sincerely yours,

 

 /s/

Basil Golding, M.D.

Director

Division of Hematology

Office of Blood Research and Review

Center for Biologics

 Evaluation and Research