  


Record of Telephone Conversation, July 31, 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: 31-Jul-2012 02:00 PM        Initiated by FDA? Yes

Telephone Number: 617-871-8325

Communication Categorie(s):

1. Information Request

 

Author: TIMOTHY NELLE

Telecon Summary:

Request for clarification of Holly Springs manufacturing timeline.

FDA Participants: None

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

 

Telecon Body:

 

CBER expressed concern over Novartis’ lot consistency study (V58P9); specifically, the less-than ideal GCP conditions and the unacceptable conduct of the study investigators in subsequent clinical trials. Given these issues, CBER is evaluating whether an additional lot consistency study should be pursued.  If CBER decides that an addition lot consistency study is needed, it would be important to consider whether the new study should use FLUCELVAX produced in Holly Springs or Marburg, or both.  As such, if Novartis’ ultimate plan is to only market FLUCELVAX produced at the Holly Springs facility (and eventually cease import of FLUCELVAX produced in Marburg), CBER may consider recommending the new lot consistency study be conducted using only material from the Holly Springs facility. 

 

CBER would envision this being a post-marketing commitment.

 

Novartis indicated that their tentative plan is to bring Holly Spring completely online --------------(b)(4)----------------------------. At that time, they would no longer market Marburg-produced-FLUCELVAX in the US. 

 

CBER requested that Novartis submit a written statement regarding this plan to the BLA. Novartis agreed.