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
Franklin T. Stephenson
Regulatory Project Manager
Information provided by: F. Stephenson Date: 10/5/2007
Approved by L. Landow 10/5/2007 Transmitted by F. Stephenson Date: 10/5/2007