
Record of Telephone Conversation, May 23, 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: 23-May-2012 01:00 PM        Initiated by FDA? Yes
 

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

Communication Categorie(s):
1. Information Request

Author: KIRK PRUTZMAN
 

Telecon Summary:
 

LRP and carton labeling comments.  
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN, TINA ROECKLEIN
Non-FDA Participants: JODY GOULD, NORRIS PYLE
 

Trans-BLA Group: No

 

Related STNs: None
 

Related PMCs: None
 

Telecon Body:
 

CBER and GSK met to discuss remaining issues with the LRP and outer carton labeling.  
 

Regarding the LRP:
 

CBER indicated that there was a typo on page 5.  GSK acknowledged the typo. CBER indicated that –b(4)-content was reported in “—b(4)--------------” units and should be reported in –b(4)---------- units.  CBER also indicated that the header of the LRP had formatting errors that moved the word “vaccine” to the next line of the header and in some places the “e” in vaccine was cut-off.  GSK agreed to make the necessary changes. 

Regarding the Carton Labeling:
 

GSK discussed their plans for labeling the vials and cartons with lot numbers and expiry dating.  They were follows:
 

Diluent box and vial 
Batch number: Diluent Batch Number
Expiry date: expiry date of diluent

Combo box 
Batch number: Vaccine Batch Number
Expiry date: earliest date between expiry date of diluent and expiry date of antigen

Antigen box and vial 
Batch number: Vaccine Batch Number  (= same as the one on combo box)
Expiry date: earliest date between expiry date of diluent and expiry date of antigen (= same as the one on combo box)

----b(4)------------------------------------------------------------------------------------------------------------------------

CBER asked GSK to send an updated “table of amendments” with their next amendment.
Call Ended.
