Major Amendment Acknowledge Letter - Ruconest

DEPARTMENT OF HEALTH & HUMAN SERVICES
 Public Health Service

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


Our STN:  BL 125495/0

Pharming Group NV
 Attention:  Ms. Zohra Lomri
 Salix Pharmaceuticals, Inc.
 8510 Colonnade Center Drive
 Raleigh, NC  27615

Dear Ms. Lomri:

We received your February 6, 2014 amendment to your biologics license application (BLA), submitted under section 351 of the Public Health Service Act (42 U.S.C. 262), for C1 Esterase Inhibitor (Recombinant) on February 6, 2014.

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 July 16, 2014.

If you have any questions, please contact the Regulatory Project Manager, Nannette Cagungun, at (301) 827-6174.

Sincerely yours,

 

Basil Golding, MD 
 Director 
 Division of Hematology
 Office of Blood Research and Review    
 Center for Biologics 
 Evaluation and Research
