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Vaccines, Blood & Biologics

Record of Telephone Conversation - Agriflu, October 29, 2008

System Info - 107006 MCWATTERS, BERNARD 06-Oct-2009 15:11:51 MCWATTERS


Submission Type: Original Application Submission ID: 125297/0 Office: OVRR

Influenza Vaccine

Novartis Vaccines and Diagnostics, Inc.

Telecon Date/Time: 29-OCT-2008 12:00 AM Initiated by FDA? No
Telephone Number:

Communication Categorie(s):


Telecon Summary:
A summary of some manufacturing changes and data submission to be made in Janruaru 2009.

FDA Participants:

Non-FDA Participants:

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear JP,

I am writing this email as follow up to my voice messages regarding two data packages we would like to submit as amendments during the Agrippal BLA review.
Following completion of the 2008 influenza campaign Novartis intends to submit two CMC (Module 3) data packages to supplement the Agrippal BLA. It is anticipated that both data sets will be available in Jan 2009.

First, as we have discussed with FDA extensively (re: Mary Malarkey, OCBQ) earlier in September, the staked needle presentation distributed with Fluvirin was challenging in the US market for 2008. To better support the US region we plan to switch to the preferred --b(4)-- presentation for both Fluvirin and Agrippal. The January 2009 submission will include Agrippal data on the selected --b(4)-- container intended to be filled in Novartis’ -b(4)- filling lines: (1) DMF cross-reference authorization, (2) Process Validation data, (3) Media fill data, (4) container closure integrity testing, and (5) three month final product stability data. In this package we will also be providing the outstanding equipment qualification data for the -b(4)- line.

Second, based on review of 2008 manufacturing data, the company will be introducing one or more optimization measures to improve control of the --b(4)-------------------- procedure. It is noted that the data provided in the BLA, which covered up to the 2007 manufacturing campaign, remains largely unaffected by the process improvements. The changes will be introduced based on the process validation results for the H3N2 strain where an ---------b(4)------------------ was required in contrast --b(4)-------- hrs for the H3N1 and B strains respectively.

The January data package related to optimization of -----b(4)------------ may include information on minor adjustments to the routine ------b(4)--- conditions (e.g.,--b(4)---- and/or equipment modifications), and /or to testing parameters.

Novartis is seeking agreement from the Agency on the filing of these data packages as amendments to BLA 125297. The Company intends to submit the amendments electronically through the gateway, as updates to the specific CTD sections. Novartis wishes to further confirm with the Agency that these data packages may be reviewed during the first review cycle with the original BLA that is currently under active review.
Please don’t hesitate to contact me if you have any questions.
Kind regards,


Joanne Totosy de Zepetnek, PhD
Vaccine Regulatory Affairs - North America
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue
Cambridge, MA 02139-4182
Tel: (617) 871-7929
Fax: (617) 871-4711
Mobile: (617) 460-2376

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