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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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9/13/2007 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 response to the following question in the form of an amendment to the file by COB 21-Sep-2007 in order to continue the review.

  1. The mean number average molecular weight (Mn) is the major determinant of the oncotic pressure that the volume expander develops, and the mean weight average molecular weight (Mw) does not directly relate to oncotic pressure. Although you showed statistical correlation between Mn and Mw based on historical data, please include Mn in the drug substance specifications and stability testing parameters, establish the parameters and/or provide rationale, e.g. Mn of fraction >-------------.

     

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: 9/13/2007

Approved by Y. Jia   Date 9/7/2007   Transmitted by F. Stephenson   Date: 9/13/2007