Record of Telephone Conversation, May 7, 2012 - MenHibrix

Sub mission Type: BLA Sub mission ID: 125363/0 Office: OVRR Product:

Meningococcal Groups C and Y and Ha e mophil us b Tetanus Toxoid Conjugate Vaccine

Applicant:
GlaxoSmithKline Biologicals

Telecon Date/Time: 07-May-2012 1500 Initiated by FDA? Yes

Telephone Number: --------b(4)-----------

Communication Categorie(s):
1. NDC 58160-801-05 MenCY -Hib carton container

Author: DAVID STA TEN

Telecon Summary:
The carton container use for t he kit presentation (10 vials of vaccine and diluent) has a stick er for t he lot/exp n umbers that is hand assembled and is place over the top of the carton and down the front. FDA is concerned t hat the end user cou ld rip the sticker and da mage the lot/exp nu mbers. FDA requested that the sticker be moved to a better secured area of the carton. GSK agreed. GSK also a greed to ---b(4)------------------------------------------------. This will be a for mal PMC. FDA con fir med that the sa me lot nu mber will be on the vial, vaccine carton, and the –b(4)---------

FDA Participants: Te menak, Staten

Non-FDA Participants: Gould, Pyle

Trans-BLA Group: No

Related S TNs: None

Related P MCs: None