Record of Telephone Conversation, September 14, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 14-Sep-2012 09:32 AM Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
1. Information Request
2. Labeling via FAX/e-mail
Author: TIMOTHY FRITZ
CBER ID tests, ----(b)(4)----, syringe label comments.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Fritz, Timothy
Sent: Friday, September 14, 2012 9:32 AM
To: 'Gollwitzer, Matthew'
Subject: CBER Information Request for STN 125408
Dear Mr. Gollwitzer-
We have reviewed your September 11, 2012, submission (Serial 29) to STN 125408. We have the following requests for additional information which were initially communicated to Novartis via e-mail on July 23, 2012. We have also reviewed your August 21, 2012, submission (Serial 25) to STN 125408 and are providing comments regarding the Flucelvax container (syringe) label.
Serial 29 Comments
1. Because the A/Victoria/361/2011 IVR-165 reassortant virus was passaged ------(b)(4)-------, please provide (b)(4) test results for ---------(b)(4)-----------------------------------------.
2. Please include CBER identity confirmation letters for the working virus seeds.
Flucelvax container comments
3. Please include the expiration date on the detachable portion of the label.
4. On the non-detachable portion of the label, we recommend increasing the font size for the proper name ("INFLUENZA VIRUS VACCINE"), the proprietary name ("FLUCELVAX") and the influenza season information.
5. On the non-detachable portion of the label, we recommend including the age range information and the text "Rx only".
These label recommendations are being made to improve the readability of the label and to be consistent with our recommendations to other influenza virus vaccine manufacturers.
Please submit the requested information as an amendment to STN 125408 as soon as possible. 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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