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
