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Vaccines, Blood & Biologics

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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