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Record of Telephone Conversation - Agriflu, January 30, 2009
(System Info - 110471 MCWATTERS BERNARD 11/10/2009 11:25:37 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA
Submission ID: 125297/0
Product: Influenza Vaccine
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 30-Jan-2009 3:30 PM
Initiated by FDA? No
Author: BERNARD MCWATTERS
Telecon Summary: Advice about the proprietary name review.
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Novartis representative Joanne Totosy de Zepetnek called me and asked for further information about submission of PNR requests. I told her that no new submission was necessary and that the PNR would happen within 90 days of the action due date, May 11, 2009. I told her that they should submit a request for a new name as soon as possible if Agrippal was not going to be their final name.