
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.

 

 
