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Record of Telephone Conversation - Agriflu, June 8, 2009
System Info - 96332 MCWATTERS, BERNARD 10-Jun-2009 11:08:45 MCWATTERS
RECORD OF TELEPHONE CONVERSATION
Submission Type: Original Application
Submission ID: 125297/0
Office: OVRR Product: Influenza Vaccine
Applicant: Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 08-JUN-2009 02:21 PM
Initiated by FDA? Yes
Author: BERNARD MCWATTERS
Telecon Summary: Emailed Joanne Totosy de Zepetnek to inform Novartis that Agriflu was an acceptable proprietary name.
FDA Participants: Bernard McWatters
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
In discussions with my supervisors, it was determined that a signed letter is not necessary to inform you of the proprietary name review. I have put the official language in this communication.
We have reviewed your submission dated March 13, 2009 to your biologics license application (BLA) for seasonal influenza vaccine, inactivated, STN 125297/0, requesting a proprietary name review.
In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, Agriflu, is acceptable at this time.
We will perform another proprietary name review of Agriflu closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
Please contact me if you have any questions. You should not expect further communication for the first proprietary name review.