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 

Telephone Number: 

Communication Categorie(s):

PNR Acceptance 

Author: BERNARD MCWATTERS 

Telecon Summary: Emailed Joanne Totosy de Zepetnek to inform Novartis that Agriflu was an acceptable proprietary name. 

FDA Participants: Bernard McWatters 

Non-FDA Participants: 

Trans-BLA Group: No 

Related STNs: None 

Related PMCs: None 

Telecon Body: 

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.