Record of Telephone Conversation - Agriflu, January 12, 2009

(System Info - 110469 MCWATTERS BERNARD 11/10/2009 11:14:39 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: 12-Jan-2009 06:58 PM

Initiated by FDA? No

Telephone Number:

Communication Categorie(s): 1. Other -

Author: BERNARD MCWATTERS

Telecon Summary: Novartis asked about data files submitted, PNR, strain change and the formatting of their electronic submissions.

FDA Participants: Bernard McWatters

Non-FDA Participants: Joanne Totosy de Zepetnek

Trans-BLA Group: No

Related STNs: None

Related PMCs: None

Telecon Body:

Dear JP,

To follow up on the voice message I left you earlier today, there are 4 things I would like your feedback on.

1. Incorrect clinical data files - HI retest data
   It has come to my attention that 3 clinical data files need to be replaced as the wrong files were submitted in the original Agrippal BLA:
   V58P2: both LABSEDT.XPT and SAMPLEVU.XPT
   V58P4: SAMPLEVU.XPT
   We plan to submit these 3 replacement files later this week. Please let me know if you have any questions.
2. Request for Proprietary Name
   Novartis originally filed a request to review the proposed Agrippal Brand Name to BB-IND -b(4)--on 22-Mar-2007 (S/N 0001). The name was accepted with concerns, and we were asked to request another proprietary name review closer to the time of approval (see attached response dated 31-Mar-2008). I was planning to file the new request to the IND, like the last one, and would like you to confirm that this approach is acceptable.
3. 2009 Annual Strain Change Update
   The Annual Strain Change Updates are usually filed in the March-April time frame. Since this is prior to the BLA Action Date, we will need to file this data package as an amendment to the BLA. Do you agree?
4. Format of 125297/0002
   Please confirm that the format of Amendment 0002 is acceptable. If so, we will model the remaining amendments accordingly.

That's it for now. Let me know 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
Email: