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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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10/5/2007 Fax

FACSIMILE TRANSMISSION RECORD

Division of Blood Applications
1401 Rockville Pike, Suite 400N, HFM-380
Rockville, Maryland 20852-1448

FAX (301) 827-2857
TEL (301) 827-3524

FAX No. 919-881-0014
To:   W.Gerald Coln, Carolina Research on behalf of Fresenius Kabi

Information Request for STN: BN070012
The review committee for STN: BN070012 requests agreement to the following post marketing commitment as a requirement for approval. Please respond with your concurrent /agreement to the statement below in the form of an amendment to BN070012 by COB 15-Oct-2007 in order to complete the review.

"Fresenius Kabi commits to perform a multiple-dose randomized controlled trail (RCT) to be conducted in subjects with septic shock who have severe renal dysfunction, regardless of whether or not they are dialysis-dependent."

If you need clarification please call me at 301-827-6165

Thanks,

Franklin T. Stephenson
Regulatory Project Manager
FDA/CBER/DBA/OBRR/RPMB


Information provided by: F. Stephenson     Date: 10/5/2007

Approved by L. Landow   10/5/2007   Transmitted by F. Stephenson   Date: 10/5/2007