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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, September 7, 2012 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 07-Sep-2012 03:06 PM        Initiated by FDA? Yes
Telephone Number: Communicated via e-mail
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
UNII codes for 2012-2013 season.
FDA Participants: Timothy Fritz
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
 
From:                    Fritz, Timothy
Sent:                      Friday, September 07, 2012 3:06 PM
To:                         'Gollwitzer, Matthew'
Subject:                 Flucelvax UNII codes for 2012-2013
 
Importance:           High
 
Attachments:         Flucelvax 2012-2013 UNII codes.doc
 
Dear Mr. Gollwitzer-
 
CBER’s review of Novartis’ Biologics License Application STN 125408 is ongoing. Below please find a table with UNII code assignments for the 2012-2013 influenza strains and inactive ingredients.
 

Active Ingredients
Name
UNII Code
Active Ingredient
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
DES33X6VK7
Active Moiety/Basis of Strength
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
KFL1W6W9JB
Active Ingredient
INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
EU4437779D
Active Moiety/Basis of Strength
INFLUENZA A VIRUS A/VICTORIA/361/2011 IVR-165 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
K3ZB8T668I
Active Ingredient
INFLUENZA B VIRUS B/WISCONSIN/1/2010) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
GWR474LL6U
Active Moiety/Basis of Strength
INFLUENZA B VIRUS B/WISCONSIN/1/2010) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
U2F63L17ZC
 
 
 
Inactive Ingredients
-----------------(b)(4)--------
-----(b)(4)-----
------------------(b)(4)--
-----(b)(4)-----
------------------(b)(4)---------
-----(b)(4)-----
------------------(b)(4)-------------------------------------
-----(b)(4)-----
------------------(b)(4)-----------------------------
-----(b)(4)-----
--(b)(4)---
-----(b)(4)-----

 
 
If you have any questions, please contact the Regulatory Project Manager, Drs Brenda Baldwin or Timothy Fritz, at 301-796-2640 or via e-mail.
 
Thank you.
 
Timothy A. Fritz, Ph.D.
Microbiologist
FDA/CBER/OVRR/DVRPA/CMC2
WOC2 HFM-478
1451 Rockville Pike
Rockville, MD 20852
Phone: 301-796-2640
Fax: 301-827-1597
 
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