Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

Telecon - Information Request, May 4, 2009 - Menveo

System Info - 110659  VALENTI, ELIZABETH   12-Nov-2009 14:47:38  VALENTI


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

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

Novartis Vaccines and Diagnostics, Inc.          

Telecon Date/Time:  04-MAY-2009 04:43 PM              Initiated by FDA?  Yes
Telephone Number:    

Communication Categorie(s):
Information Request


Telecon Summary:
requested again 24 month stability data (both requested via email)

FDA Participants:  

Non-FDA Participants:   

Trans-BLA Group: No

Related STNs:  None

Related PMCs:  None

Telecon Body:
From:                     Fiore, Cara 
Sent:                      Monday, May 04, 2009 4:43 PM
To:                          ''
Cc:                          Valenti, Elizabeth
Subject:                Stability data

Hi Chris,

Please let me know if Novartis is planning on submitting 24 month stability data for Menveo.  We would like to see it soon, if so.


Page Last Updated: 03/24/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English