Submission Type: BLA Submission ID: 125363/0 Office: OVRR
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
Telecon Date/Time: 24-Apr-2012 11:30 AM Initiated by FDA? Yes
1. Information Request
Author: KIRK PRUTZMAN
Inquire about the status of MenHibrix Launch Lots
FDA Participants: THERESA FINN, KIRK PRUTZMAN
Non-FDA Participants: JODY GOULD, NORRIS PYLE
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
CBER called GSK to inquire about the status of the Launch Lots of MenHibrix.
1. Launch Lots: They will make a decision tomorrow on b(4) Launch Lots. The lots will either be the b(4) lots that we have in house or b(4) new lots that GSK will send to CBER. GSK explained that this decision is based on setting final specifications for the PS content of lyophilized lots reconstituted in saline vs. (b)(4) and is explained in an April 10, 2012 email.
2. The Lot Release Protocol (LRP): GSK asked us if the LRP could be finalized after approval of the product. They explained that GSK have a “change-control” process that the LRP drafts have to go through before they can be modified, thus the LRP will not be ready before June 1, 2012. We told them that seemed very unlikely but that we would discuss with OCBQ. They also indicated that they have a new/updated draft LRP that they can submit.