
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