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Vaccines, Blood & Biologics

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Record of Telephone Conversation - Agriflu, January 30, 2009

(System Info - 110471 MCWATTERS BERNARD 11/10/2009 11:25:37 MCWATTERS)


Submission Type: BLA 

Submission ID: 125297/0 

Office: OVRR

Product: Influenza Vaccine

Applicant: Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 30-Jan-2009 3:30 PM 

Initiated by FDA? No

Telephone Number:

Communication Categorie(s): 

1. Advice


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

Telecon Body: 

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.