Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Vaccine (MDCK Cells)
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 31-Jul-2012 02:00 PM Initiated by FDA? Yes
Telephone Number: 617-871-8325
1. Information Request
Author: TIMOTHY NELLE
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
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.