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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, May 18, 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: 18-May-2012 04:11 PM        Initiated by FDA? Yes
Telephone Number: norris.h.pyle@gsk.com
Communication Categorie(s):
1. Other - Carton Labeling Change
 
Author: KIRK PRUTZMAN
Telecon Summary:
Language for the Carton and Vial Label
FDA Participants: NORRIS PYLE
Non-FDA Participants: KIRK PRUTZMAN, JOSEPH TEMENAK
Trans-BLA Group: No
 
Related STNs: None
Related PMCs: None
Telecon Body:
From: Prutzman, Kirk C
Sent: Friday, May 18, 2012 4:11 PM
To: 'Norris Pyle'
Cc: Temenak, Joseph
Subject: RE: STN 125363 - vial/carton labeling
Norris,
 
Here is the final language CBER is requesting.
 
On the carton labels please include:
 
1.  "For 6 weeks through 18 months of age"
 
2.  The route of administration.
 
 
For the vial label, please include IM in to the current language.  The vial language should read:
 
"0.5 mL Single IM Dose After Reconstitution"
 
 
Let me know if this is acceptable.
 
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 18, 2012 3:53 PM
To: Prutzman, Kirk C
Cc: Temenak, Joseph
Subject: RE: STN 125363 - vial/carton labeling
Ok – Thank you.  - Norris
 
From: Prutzman, Kirk C [mailto:Kirk.Prutzman@fda.hhs.gov]
Sent: Friday, May 18, 2012 3:50 PM
To: Norris Pyle
Cc: Temenak, Joseph
Subject: RE: STN 125363 - vial/carton labeling
 
Norris,
 
I am waiting on final word regarding the vial.  We have 3 possibilities.  Hopefully I an get agreement on 1 of them. 
 
We decided NOT to include the word infants in the age group wording.  So the language will be:
 
"For 6 weeks through 18 months of age"
 
I will send another email with all of the final language as soon as I get it. 
 
Kirk

From: Norris Pyle [mailto:norris.h.pyle@gsk.com]
Sent: Friday, May 18, 2012 3:31 PM
To: Prutzman, Kirk C
Subject: FW: STN 125363 - vial/carton labeling
Hello  Kirk,
Just checking to see if there is any update on this.  Once I know the path forward, GSK should be able to submit the updated label(s) quickly (in 1-2 business days).
 
Let me know – thanks - Norris
 
 
From: Norris Pyle
Sent: Thursday, May 17, 2012 1:51 PM
To: 'Prutzman, Kirk C'
Cc: Temenak, Joseph; Staten, David; Jody Gould
Subject: RE: STN 125363 - vial/carton labeling
 
Hi Kirk,
I am going to assume this request just pertains to the vaccine, and not the diluent.  Correct me if that is wrong.
 
GSK can perform Items 1 and 2 for the vaccine carton.
 
For the vaccine vial label, GSK can’t add either Item one or Item two due to the amount of information already on the vial label.  GSK believes the partial label rule applies here. 
 
GSK has one question – does CBER want Item 1 as requested, or alternatively, would “For infants 6 weeks through 18 months of age” be better?
 
Please let me know – thank you - Norris
 
From: Prutzman, Kirk C [mailto:Kirk.Prutzman@fda.hhs.gov]
Sent: Thursday, May 17, 2012 12:36 PM
To: Jody Gould; Norris Pyle
Cc: Temenak, Joseph; Staten, David
Subject: STN 125363 - vial/carton labeling
 
Jody,
 
We would like the MenHibrix vial and carton labels to include the following:
 
1.  Age Group - "For 6 weeks through 18 months of age"
 
2.  Route of administration
 
These should be printed on the vial and carton labels with sufficient prominence to mitigate medication errors with Menomune, Menactra and Menveo.  We would like these changes to be made prior to approval of MenHibrix.
 
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