
Record of Telephone Conversation - Agriflu, November 6, 2009


 
 
(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

Product:

Influenza Vaccine

Applicant:

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 06-Nov-2009 01:56 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Information Request

Author: BERNARD MCWATTERS

Telecon Summary:

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

Telecon Body:

Joanne,

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:  
1.Influenza Virus Vaccine in place of Agriflu as the license name on every page
2.No initials at the bottom of page
•Questions on the residual kanamycin and neomycin in their vaccine:
1.Please provide data demonstrating how much kanamycin and neomycin will be removed during the manufacturing process.
2.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.

JP
