Record of Telephone Conversation, August 23, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 23-Aug-2012 12:20 PM Initiated by FDA? Yes
Author: TIMOTHY NELLE
Timing of Novartis' submission of the Trivalent Bulk samples
FDA Participants: None
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
In response to CBER’s August 17, 2012, Advice and Information Request, Novartis provided the following information regarding their proposed plans for submitting the FLUCELVAX trivalent bulk samples and Strain Change information:
Date of CBER Receipt
- 1st lot of US Trivalent Bulk + Strain Change Submission
- 2nd lot of US Trivalent Bulk
- 3rd lot of US Trivalent Bulk
CBER indicated that these timelines were acceptable, but also stated that Novartis should be aware of the following:
- The first trivalent must arrive before the current approval target date, September 21, 2012. If the first trivalent is not received by this date, then CBER may issue a Complete Response.
- Under the timeline you have provided below, CBER will plan to issue a Major Amendment once the first trivalent bulk arrives.
- Assuming that a Major Amendment is issued, we will provide a new (non-PDUFA) target date for approval after the third trivalent bulk is received.
- If problems are encountered during CBER's testing, further delay in approval may be necessary.