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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, May 25, 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: 25-May-2012 03:10 PM        Initiated by FDA? Yes
 

Telephone Number: norris.h.pyle@gsk.com, jody.a.gould@gsk.com
 

Communication Categorie(s):
1. Other -

Author: KIRK PRUTZMAN
 

Telecon Summary:
Confirmation of Lot Number and Expiry dating protocol
 

FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK, DAVID STATEN
 

Non-FDA Participants: NORRIS PYLE, JODY GOULD
 

Trans-BLA Group: No

Related STNs: None
 

Related PMCs: None
 

Telecon Body:
 From: Prutzman, Kirk C
Sent: Friday, May 25, 2012 3:10 PM
To: 'Norris Pyle'; Jody Gould
Cc: Temenak, Joseph; Staten, David
Subject: RE: MenHibrix: Lot numbering/expiry dating

Norris,

CBER concurs with your proposal below to assign lot numbers and expiry dating to the Diluent box and vial, the Vaccine box and vial, and the Combo box.

Regards,

Kirk Prutzman, PhD
Food and Drug Administration
Primary Reviewer/Regulatory Project Manager
CBER/OVRR/DVRPA/CMC3
1451 Rockville Pike (WOC2)
Room 2241
HFM-481
Rockville, MD  20857
Phone:  (301) 796-2640


From: Norris Pyle [mailto:norris.h.pyle@gsk.com]
Sent: Friday, May 25, 2012 11:59 AM
To: Temenak, Joseph; Staten, David; Prutzman, Kirk C
Cc: Jody Gould
Subject: MenHibrix: Lot numbering/expiry dating


Hello everyone,

In regards to the teleconference we had on May 23rd, and in particular the discussion on assigning lot numbers and expiry dating on the vial and carton labels, GSK would like to propose the following:

To assign one lot number for the vaccine on the vaccine vial, the vaccine inner carton, and on the combo box.  Then, as opposed to GSK’s original proposal, assign only one expiry dating to that vaccine lot number.  Thus the lot numbering/expiry dating would be assigned as follows:

Diluent box and vial
Batch number: --b(4)----
Expiry date: expiry date of diluent

Combo box
Batch number: --b(4)----
Expiry date: earliest date between expiry date of diluent and expiry date of antigen

Antigen box and vial
Batch number: --b(4)----  (= 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)

As I recall from the discussions during the teleconference on the 23rd, I believe this approach would also be acceptable to CBER.  Please confirm.

Also, as for the revised carton labels and PI, GSK will have those to you this afternoon via email for your review.

For the carton labels:

  • in regards to the comment pertaining to the age recommendation (last version was in white text with brown background), GSK is removing the brown background, changing the text to brown to match the other text, and leaving text bolded.

     
  • For you question regarding the black box, that is the area where the lot and expiration dating will be assigned.  That area is being reduced as requested.

     
  • All other requests being incorporated. 

Let me know if you have any questions.  Thank you - Norris