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