Vaccines, Blood & Biologics
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
This Fax is regarding STN: BN070012/0 that was submitted to the agency on1-March-07 as an NDA for your Voluven product. The reviewers for this application request Fresenius KAbi to amend the submission by doing the following:
1) Please submit a copy of BB-MF-----, Type II Master File for "Hydroxyethyl Starch 130/0.4 for Injection" for the facilities and equipment. BB-MF ----- is referenced in Module 3.
2) Please submit additional information for the Certificates for the Biological Indicators (BI) (section 3.2.P.3.5.2) used in the sterilization process validation studies N 1986 and N 1989.
Please submit a response to this information request as an amendment to the file by COB 01-August 2007. If we do not receive the information by this date, a complete response letter will be issued that will contain the same items enumerated above.
If you need clarification please call me at 301-827-6165
Franklin T. Stephenson
Regulatory Project Manager
Information provided by: F. Stephenson Date: June 29, 2007 2:45:01 PM
Approved by J. Kim Date June 29, 2007 Transmitted by F. Stephenson Date: 6/29/2007