(System Info - 112480 MCWATTERS BERNARD 12/01/2009 16:54:33 MCWATTERS)
RECORD OF TELEPHONE CONVERSATION
Submission Type: BLA Submission ID: 125297/0 Office: OVRR
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 06-Nov-2009 01:56 PM Initiated by FDA? Yes
1. Information Request
Author: BERNARD MCWATTERS
Advised Novartis about their LRP and asked them to submit information about residual kanamycin and neomycin.
FDA Participants: Bernard McWatters
Non-FDA Participants: Joanne Totosy de Zepetnek
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
I have received a lot of information to send you today:
CBER has completed -b(4)- test on samples of monovalent bulks lots for all 3 strains of influenza virus for the 2009-10 season. Your results on the b(4) content (determined by b(4)- of all samples for all the 3 strains are within 20% of CBER's results. Our results are attached herewith for your information.
- Comments on the LRP:
- Influenza Virus Vaccine in place of Agriflu as the license name on every page
- No initials at the bottom of page
- Questions on the residual kanamycin and neomycin in their vaccine:
- Please provide data demonstrating how much kanamycin and neomycin will be removed during the manufacturing process.
- Kanamycin and neomycin concentrations were not reported in the release testing of the --b(4)-------------------------------- or final container. Do you have any historical data to demonstrate the concentration of the residual kanamycin and neomycin in the --b(4)-------------------------------- or final container? Alternatively, please provide a mathematical estimate of how much will be present in the final container.
- Comments on the Package Insert will be sent to you by close of business today.
Let me know if you have any questions.