Memo of Telecon with Novartis - Agriflu, October 1, 2009

Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Memorandum
Date: October 1, 2009
To: File, BL 125297/0
From:  Rebecca Olin, CBER/OCBQ/DMPQ/MRBII
Subject:  Memo of Telecon with Novartis

On October 1, 2009, Joanne Totosy de Zepetnek, PhD, Vaccine Regulatory Affairs, North America, Novartis, called me with a question regarding a post approval submission in support of the use of --b(4)---------------- ----- filters at the -b(4)--------- filtration step for the monovalent bulks.  Briefly, Novartis submitted in the original BLA submission,     -b(4)--filters to be used for -b(4)-------- filtration of the monovalent bulks; however, sufficient data was provided for only the -b(4)---- filter.  There was incomplete data to support Novartis’ claim that the ----b(4)---------------- filters were equivalent to the            -b(4)------.   Novartis was asked on several occasions to provide data to support equivalence but complete data was not provided.  As a result of continued questioning, Novartis committed to submit additional information after approval of the Agriflu BLA in support of the ---b(4)----------filters.  During the telecon of October 1, 2009, Joanne Totosy asked me how data supporting the --b(4)---------------- filters should be submitted.  I spoke with Supervisor Carolyn Renshaw and Division Director John Eltermann and both agreed that their submission should come in as a PAS.  John Eltermann suggested that they submit a Comparability Protocol.  I conveyed this information to Dr. Totosy and the telecon was completed.