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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Memo - XYNTHA

MEMORANDUM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

DATE June 8, 2007
FROM Bhanu Kannan, Bioresearch Monitoring Branch, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
TO Timothy Lee, HFM-392
Chair, BLA Licensing Committee
SUBJECT Filing Memo
SPONSOR: Wyeth
PRODUCT: Moroctocog alfa (AF-CC)
BLA: STN 125264/0

Summary:

Our review of the BLA submission notes that there are no filing issues and the filing of the submission appears to be adequate for the Bioresearch monitoring review purposes.

Should you have any questions or comments about the contents of this memo or any aspect of Bioresearch Monitoring, please contact me at 301-827-6188.

___________________
Bhanu Kannan