
Record of Telephone Conversation, 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 02:40 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: DAVID STATEN

Telecon Summary:

FDA decision on temp storage for diluent

FDA Participants: None

Non-FDA Participants: None

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

 

After internal discussion, FDA conveyed to GSK that their “batching” of storage data is acceptable. The storage condition for the PI and labels/carton will read;

 

 "Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F). Do not freeze. Discard if the diluent has been frozen"

 