• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Section Contents Menu


Record of Telephone Conversation, 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 02:40 AM        Initiated by FDA? Yes
Telephone Number:
Communication Categorie(s):
1. Advice
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"