
Record of Telephone Conversation, September 14, 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: 14-Sep-2012 09:32 AM        Initiated by FDA? Yes

Telephone Number: Communicated via e-mail

Communication Categorie(s):

1. Information Request

2. Labeling via FAX/e-mail

Author: TIMOTHY FRITZ

Telecon Summary:

CBER ID tests, ----(b)(4)----, syringe label comments.

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 14, 2012 9:32 AM

To:                         'Gollwitzer, Matthew'

Subject:                 CBER Information Request for STN 125408

 

Importance:           High

 

Dear Mr. Gollwitzer-

 

We have reviewed your September 11, 2012, submission (Serial 29) to STN 125408. We have the following requests for additional information which were initially communicated to Novartis via e-mail on July 23, 2012. We have also reviewed your August 21, 2012, submission (Serial 25) to STN 125408 and are providing comments regarding the Flucelvax container (syringe) label.

 

Serial 29 Comments

 

1. Because the A/Victoria/361/2011 IVR-165 reassortant virus was passaged ------(b)(4)-------, please provide (b)(4) test results for ---------(b)(4)-----------------------------------------.

 

2. Please include CBER identity confirmation letters for the working virus seeds.

 

Flucelvax container comments

 

3. Please include the expiration date on the detachable portion of the label.

 

4. On the non-detachable portion of the label, we recommend increasing the font size for the proper name ("INFLUENZA VIRUS VACCINE"), the proprietary name ("FLUCELVAX") and the influenza season information.

 

5. On the non-detachable portion of the label, we recommend including the age range information and the text "Rx only".

 

These label recommendations are being made to improve the readability of the label and to be consistent with our recommendations to other influenza virus vaccine manufacturers.

 

Please submit the requested information as an amendment to STN 125408 as soon as possible. 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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