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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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1/25/2008 Telecon - XYNTHA

Telecon with Wyeth

DATE, TIME:   Wednesday, January 25, 2008. 4:15 pm
REASON FOR CALL - STN 125264/0 on Labeling

Meeting called by: Wyeth
Pauline Cottrell/ RPM

Type of meeting: Telecon

Telecon: Phone 484-865-5938

FDA Participants:
Pauline Cottrell
Nisha Jain

Wyeth Participants:
Joyce Schwenk

Re: STN 125264/0 Antihemophilic Factor (Recombinant), Plasma/Albumin-Free.

Conversation Record:

Wyeth called with questions on the current version of the PI. Dr. Jain answered their questions. Wyeth they would be sending the revsions by Jan. 31.