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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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First Committee Meeting Summary - XYNTHA

MEMORANDUM

DATE: May 16, 2007
FROM: Pauline Cottrell, DBA, HFM-380
RE: First Committee Meeting Summary for STN: 125264/0
ATTENDEES: Pauline Cottrell, Franklin Stephenson, Boris Zaslavsky, Bhanu Kannan, Robert Stevenson, Nisha Jain, Timothy Lee, Paul Buehler, Iftekhar Mahmood, and Catherine Miller,
Sponsor: Wyeth Pharmaceuticals
Product: Antihemophilic Factor (Recombinant )Plasma/Albumin Free Method
DUE DATE: 22-Feb-2008
TO: File

This BLA under STN : 125264/0 was received on 25-April-2007 from Wyeth Pharmaceuticals for their Antihemophilic Factor (Recombinant )Plasma/Albumin -free. This drug represents a modified drug substance manufacturing process from the currently approved product ReFacto. Robert he would call Wyeth directly for the inspection history of the facilities.

The review committee indicated that after an initial review of the submission it appeared to be complete although they may later request additional clarification of some of the information/data submitted.