
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

 

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.