Record of Telephone Conversation, July 24, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 24-Jul-2012 11:19 AM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
Author: TIMOTHY FRITZ
Age stratified results for study V58P4.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Tuesday, July 24, 2012 11:19 AM
To: 'Gollwitzer, Matthew'
Subject: CBER Information request: STN 125408
Dear Mr. Gollwitzer-
CBER’s review of Novartis’ submission STN 125408 is ongoing. We have the following requests for additional information:
1. Because the Package Insert presents results from Study V58P4 by age groups 18-64 years and 65 years and older, please provide the results of Study V58P4 stratified by these age groups. We recommend submission of an addendum to STN 125408 with each of the tables currently contained in the body of the Clinical Study Report with results recalculated for these age groups (18-64 years and 65 years and older). No additional text is needed.
2. Please submit the Case Report Forms for the three deaths and the three pregnant females in Study V58P4.
Please submit the requested information as an amendment to STN 125408. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
Timothy A. Fritz, Ph.D.
1451 Rockville Pike
Rockville, MD 20852
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