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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2/6/2008 Telecon - XYNTHA

Telecon with Wyeth

DATE, TIME:   Wednesday, February 06, 2008
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:

After QC of the current revision of the PI by Wyeth some discrepancies were found and a revised PI was sent to Wyeth via email, per their request. FDA called in response to the email Wyeth sent, in return, to note the changes before they proceeded to make these changes to the PI. Dr. Jain went over these changes and Wyeth said they would send the revised PI by noon tomorrow, Feb. 7, 2008.