Telecon - Leachable in stopper, October 15, 2009 - Menveo

System Info - 108501  SHONE, DEANNA   22-Oct-2009 11:23:03  SHONEDE

RECORD OF TELEPHONE CONVERSATION

Submission Type: Original Application   Submission ID:  125300/0    Office: OVRR  

Product:
Meningococcal [Groups A, C, Y, and W 135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Applicant:                                                                       
Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  15-OCT-2009 02:25 PM                Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Other

Author:  NABIL AL-HUMADI

Telecon Summary:
Leachable in stopper

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
______________________________________________
From:                     Al-Humadi, Nabil 
Sent:                      Thursday, October 15, 2009 2:25 PM
To:                          Fiore, Cara; Trudel, Nicole
Cc:                          Sutkowski, Elizabeth M.; Vann, Willie; Valenti, Elizabeth
Subject:                RE: Leachable in stopper

Hi Cara,

Novartis submitted a copy of the study report (Technical Report RT 08/338 - Leachable studies report for MenCWY Liquid filled in vials - time point 12 months) and is reported in Module 3.2.P.2.4 (MenCWYLiquid). Their response adequately addresses the request for information.

The amount of --b(4)-------------------- as reported in Novartis' study report is actually 106                 ---b(4)---------------------------------------------- as it was reported previously to the toxicology team.

No component of this product is present at levels greater than or equal to -b(4)- or is identified as a probable, possible or confirmed human carcinogen by lARC, ACGIH, NTP, and OSHA standards. However, --b(4)----------- is, as it was reported by OSHA, harmful by ingestion, toxic by skin absorption, and an irritant. -----b(4)--------------------------------------------------------------------------------------------

Taking into consideration the low level of this compound as reported in Novartis' extraction study and nature of its toxicities, this level of --b(4)----------------- does not possess a safety concern.

Thanks,

Nabil H. Al-Humadi, MS, MS, Ph.D.
FDA/CBER/OVRR
1401 Rockville Pike,
Rockville, MD 20852 
Ph.: (301) 827-3070