
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.
