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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, June 12, 2012 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics, Inc.
 
Telecon Date/Time: 12-Jun-2012 10:00 AM        Initiated by FDA? Yes
 
Telephone Number: 617-871-8325
 
Communication Categorie(s):
1. Advice
 
Author: TIMOTHY NELLE
 
Telecon Summary:
Informal request to discuss Proprietary Name review
 
FDA Participants: Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
 
Telecon Body:
Novartis called to request an informal meeting between Novartis and APBL reviewers to discuss the recent rejection of the OPTAFLU proprietary name and get a sense of which of their current back-up names may be acceptable. 
CBER explained the reasoning for the rejection of the OPTAFLU name was due to new guidelines that APBL must follow. Furthermore, it was explained that APLB could not comment on the acceptability of new proposed names without first receiving those names and supporting information in an official submission. Thus, CBER would not be able to provide such feedback in such a meeting format.
 
It was recommended that Novartis submit their new proprietary name proposals to the BLA as soon as possible.
Novartis also stated that they are considering challenging the rejection of the OPTAFLU name and were interested in seeing if they could reverse APBL’s decision by discussing the issue with the review team. CBER recommended that if they wish to challenge the rejection of the OPTAFLU name that they could do so by contacting DVRPA management first.