
PNA Letter - Intersol


 
 
Our STN: BN 080041/0


Fenwal, Inc.
 Attention: Mr. Matthew Nowland
 Three Corporate Drive
 Lake Zurich, IL 60047


Dear Mr. Nowland:


We have reviewed your submission dated June 5, 2009, to your new drug application (NDA) for InterSol Solution requesting a proprietary name review.


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


We will perform another proprietary name review of InterSol Solution 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 the Regulatory Project Manager, Heather Erdman, at (301) 827-6182.


Sincerely yours,

 

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