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Vaccines

Record of Telephone Conversation, August 23, 2012 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 23-Aug-2012 12:20 PM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
 
Author: TIMOTHY NELLE
Telecon Summary:
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
Telecon Body:
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:

Sample/Strain-change submission
Date of CBER Receipt
  •  1st lot of US Trivalent Bulk + Strain Change Submission
09/18/2012
  •  2nd lot of US Trivalent Bulk
09/21/2012
  • 3rd lot of US Trivalent Bulk
09/26/2012

 
CBER indicated that these timelines were acceptable, but also stated that Novartis should be aware of the following:
 
  1. 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.
  2. Under the timeline you have provided below, CBER will plan to issue a Major Amendment once the first trivalent bulk arrives. 
  3. 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.
  4. If problems are encountered during CBER's testing, further delay in approval may be necessary.