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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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"