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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Letter - Intersol

Fenwal, Inc.
Attention: Ms. Cheryl Chamberlain Roscher
Three Corporate Drive
Lake Zurich, IL 60047

Re: BN080041

Dear Ms. Chamberlain Roscher:

This letter is in regard to your new drug application to include InterSol Solution submitted under Section 351 of the Public Health Service Act.

The Center for Biologics Evaluation and Research has completed an initial review of your application dated 31-JUL-08 to determine its acceptability for filing. In accordance with 21 CFR 314.70(c) the application is considered to be filed effective today’s date.

This acknowledgment does not mean that this application has been approved nor does it represent any evaluation of the adequacy of the data submitted. Following a review of this submission, we shall advise you in writing as to what action has been taken and request additional information if needed.

Should you need additional information of have any questions concerning administrative or procedural matters please contact Heather Erdman at (301) 827-6182.

Sincerely yours,

Heather Erdman, RAC
Regulatory Project Manager
Division of Blood Applications
Office of Blood Research and Review
Center for Biologics
Evaluation and Research