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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Meeting Summary - XYNTHA


Date: 6-Jun-07
From: Pauline Cottrell, DBA, HFM-380
RE: Filing Meeting Summary for STN:125264/0
ATTENDEES: Pauline Cottrell, Tim Lee, Nisha Jain, Paul Buehler, Iftekhar Mahmood, Boris Zaslavsky, Catherine Miller, Bhanu Kannan, Daniel Kearns
Sponsor: Wyeth
Product: Antihemophilic Factor (Recombinant), Plasma/Albumin Free
DUE DATE: 22-Feb-08
TO: File

The SL indicated to me that STN: 125264/0 Antihemophilic Factor (Recombinant), Plasma/Albumin-free from Wyeth requesting CBER to eliminate the use of animal-and human-derived proteins resulting in the development of the ReFacto AF manufacturing process, may be filed. He may later request additional clarification of some of the information/data submitted.