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