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:  Mr. Matthew E. Moran
 Santarus, Inc. 
 3611 Valley Centre Drive, Suite 400
 San Diego, CA  92130

Dear Mr. Moran:

 

We have reviewed your submission dated April 16, 2013 to your biologics license application (BLA) for C1 Esterase Inhibitor (Recombinant) requesting a proprietary name review. 

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that your proposed proprietary name, RUCONEST, is acceptable at this time under the Federal Food, Drug, and Cosmetic Act and applicable regulations.

We will perform another proprietary name review of RUCONEST closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.

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

Sincerely yours,

/s/

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