Record of Telephone Conversation, April 24, 2012 - MenHibrix

Submission Type: BLA    Submission ID: 125363/0    Office: OVRR
 

Product:
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
 

Applicant:
GlaxoSmithKline Biologicals
 

Telecon Date/Time: 24-Apr-2012 11:30 AM        Initiated by FDA? Yes
 

Telephone Number:
 

Communication Categorie(s):
 

1. Information Request

Author: KIRK PRUTZMAN
 

Telecon Summary:
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
 

Telecon Body:
 

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. 
 

Call Ended.