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Vaccines, Blood & Biologics

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Vaccines

Record of Telephone Conversation, December 15, 2011 - Flucelvax

 

Submission Type: BLA    Submission ID: 125408/0    Office: OVRR
Product:
Influenza Vaccine (MDCK Cells)
Applicant:
Novartis Vaccines and Diagnostics GmbH
Telecon Date/Time: 15-Dec-2011 09:59 AM        Initiated by FDA? Yes
Telephone Number: Communication conveyed via e-mail
Communication Categorie(s):
1. Advice
Author: TIMOTHY FRITZ
Telecon Summary:
Advice to submit request for new proprietary name review.
FDA Participants: Timothy Fritz
Non-FDA Participants: Ingeborg Cebulla, John Barry
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
Telecon Body:
 
From:                    Fritz, Timothy
Sent:                      Thursday, December 15, 2011 9:59 AM
To:                         'ingeborg.cebulla@novartis.com'
Cc:                         'john.barry@novartis.com'
Subject:                 Optaflu Proprietary Name Review Request
 
Importance:           High
 
Dear Dr. Cebulla-
 
CBER’s July 19, 2007, letter issued under IND 11580 in reference to the proprietary name review of OPTAFLU stated that Novartis Vaccines and Diagnostics, Inc is required to request a new proprietary name review of OPTAFLU if more than 90 days have passed since the date of the CBER letter and licensure of OPTAFLU. Because this condition has been met, Novartis is required to submit a request for a new proprietary name review for OPTAFLU. Please submit this request as an amendment to the OPTAFLU BLA (STN 125408) and provide CBER with any updated information regarding the proposed OPTAFLU name. It is not necessary for Novartis to resubmit the information already provided on September 29, 2006, to IND 11580 as copied in Module 1.12.4 of the OPTAFLU BLA original submission.
 
If you have any questions, please contact the Regulator Project Managers, Dr. Brenda Baldwin or Dr. 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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