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Vaccines, Blood & Biologics

Record of Telephone Conversation, August 2, 2012 - Flucelvax


Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Influenza Virus Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 02-Aug-2012 08:40 AM        Initiated by FDA? No
Telephone Number:
Communication Categorie(s):
1. Other - annual strain change information
Telecon Summary:
NVD does not desire major amendment
FDA Participants: Brenda Baldwin, Timothy Fritz, Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
E-mail Body:
From: Gollwitzer, Matthew []
Sent: Thursday, August 02, 2012 8:40 AM
To: Fritz, Timothy; Baldwin, Brenda; Nelle, Timothy
Subject: 125408 - Novartis' Annual Strain Change Proposal
Sensitivity: Confidential
The following outlines Novartis’ proposal for submission of the Annual Update Strain Change Supplement in addition to projected timelines for providing CBER the requested US monovalent and trivalent bulks.  Novartis remains committed to distributing ---(b)(4)-doses to support the 2012-2013 influenza season. 
FDA Communication:
As communicated in an email on July 23rd, both the submission of an Annual Strain Change Update Supplement after August 12th and the submission of the monovalent and trivalent bulk samples after August 17th, would result in a major amendment and delay in the PDUFA action date.
Novartis Response:
Although Novartis is unable to meet these timelines, Novartis would like to avoid any delay in the PDUFA action date for the Flucelvax application and potential approval on target.  Therefore the submission of a major amendment on August 17th is not our preferred option.   Instead we propose the following plan for submission of the Annual Update and projected timelines for providing the monovalent and trivalent bulk samples for CBER testing and release.
  • Novartis proposes to submit the Annual Strain Change Update immediately following approval (current target based on Action Letter Date of Sept 21, 2012) as a Prior Approval Supplement (PAS); Novartis understands that a PAS carries a 4 month PDUFA review date, however, given our commitment previously to CBER and desire to launch product in time for the 2012/13 season, we would appreciate consideration of a one month review of the supplement.  This short timeline is based on the following:
    • The PAS would have information already approved and reviewed by CBER before the action date (for example the labeling and CBER identity confirmation letters)  
    • In order to expedite the testing of the monovalent and trivalent bulk samples, Novartis proposes to submit the samples to CBER on a rolling basis (to Dr. Gupta’s lab)in advance of the strain change supplement; We can begin submitting in August with all samples submitted prior to the action due date
    •  With approximately a one month CBER testing period, we could then potentially have release of first lots of product across October, allowing for launch end Oct/November
Please let us know if you have any questions and if this plan is generally acceptable by CBER.
Kind Regards,


Page Last Updated: 12/19/2012
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