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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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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
 
THIS MESSAGE IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND MAY CONTAIN INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DISCLOSURE UNDER LAW. If you are not the addressee, or a person authorized to deliver the document to the addressee, you are hereby notified that any review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If you have received this document in error, please notify the sender immediately by e-mail or phone.
 
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