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Vaccines, Blood & Biologics

Record of Telephone Conversation, Storage Temps, June 1, 2012 - MenHibrix

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

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

GlaxoSmithKline Biologicals

Telecon Date/Time: 01-Jun-2012 02:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):
1. Advice


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.

Page Last Updated: 07/15/2012
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