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