
Record of Telephone Conversation, July 24, 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: 24-Jul-2012 11:19 AM        Initiated by FDA? Yes

 

Telephone Number: Communicated via e-mail

 

Communication Categorie(s):

1. Information Request

 

Author: TIMOTHY FRITZ

 

Telecon Summary:

Age stratified results for study V58P4.

 

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:                      Tuesday, July 24, 2012 11:19 AM

To:                         'Gollwitzer, Matthew'

Subject:                 CBER Information request: STN 125408

 

Importance:           High

Dear Mr. Gollwitzer-

 

CBER’s review of Novartis’ submission STN 125408 is ongoing. We have the following requests for additional information:

 

1. Because the Package Insert presents results from Study V58P4 by age groups 18-64 years and 65 years and older, please provide the results of Study V58P4 stratified by these age groups. We recommend submission of an addendum to STN 125408 with each of the tables currently contained in the body of the Clinical Study Report with results recalculated for these age groups (18-64 years and 65 years and older). No additional text is needed.

 

2. Please submit the Case Report Forms for the three deaths and the three pregnant females in Study V58P4.

 

Please submit the requested information as an amendment to STN 125408. We recommend that you restate each item and follow it with your explanation or clarification. Use of this format helps organize the relevant information and provides a self-contained document that facilitates future reference.

 

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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