Record of Telephone Conversation, Storage Temps, June 1, 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: 01-Jun-2012 02:00 AM        Initiated by FDA? Yes
 

Telephone Number:
 

Communication Categorie(s):
1. Advice

Author: DAVID STATEN
 

Telecon Summary:
 

Discussion on storage temps for the diluent
 

FDA Participants: None
 

Non-FDA Participants: None
 

Trans-BLA Group: No

Related STNs: None
 

Related PMCs: None
 

Telecon Body:

GSK data only supports storage of the diluent at 2-8 and 20-25C.  These data does not support storage at intermediate temperature.

GSK stated that they -----b(4)-------------------------------------------------------------------- for their stability studies, and can't imagine what might happen at the in-between temps (--b(4)---------------).  GSK stated  that this '—b(4)------' and using the entire span of the temps (2-25 degrees C) to describe storage conditions was somehow in accordance with ICH guidelines.  If FDA required GSK to change the label/carton language NOW, GSK stated it would take at least a few days to turn this

We conveyed to them that this issue was being discussed internally, and that I'd get back with them TODAY.