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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Resubmission Acknowledgement Letter Class 2 - Intersol

Our STN: BN 080041/0

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

 

Dear Mr. Nowland:

We received your June 11, 2009, resubmission to your new drug application (NDA) for InterSol Solution on June 12, 2009.

The resubmission contains additional CMC, clinical, statistics, toxicology/leachables materials, and compliance information that you submitted in response to our April 6, 2009, complete response letter.

We consider this a complete, class 2 response to our action letter. Therefore, the user fee goal date is December 12, 2009.

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