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Vaccines

Record of Telephone Conversation, July 10, 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: 10-Jul-2012 12:00 PM        Initiated by FDA? Yes
Telephone Number: 617-871-8325
 
Communication Categorie(s):
1. Information Request
 
Author: TIMOTHY FRITZ
 
Telecon Summary:
US and EU syringe and plunger/rubber stopper.
FDA Participants: Timothy Fritz
 
Non-FDA Participants: Matthew Gollwitzer
 
Trans-BLA Group: No
 
Related STNs: None
 
Related PMCs: None
 
Telecon Body:
Mr. Gollwitzer was asked whether the syringe and rubber stopper, for which information was submitted to STN 125408 for US licensure, were the same as those which were licensed in the European Union (EU). Mr. Gollwitzer said that he would provide that information to FDA as soon as possible. In an e-mail sent to FDA on July 12, 2012, Mr. Gollwitzer confirmed that the syringe and rubber stopper licensed in the EU were the same as those submitted for licensure in the US. The e-mail is included as an appendix below.


 

APPENDIX
 
From: Gollwitzer, Matthew [matthew.gollwitzer@novartis.com]
Sent: Thursday, July 12, 2012 12:48 PM
To: Fritz, Timothy
Subject: Optaflu - Syringe and Rubber Stopper

Sensitivity: Confidential
Hi Tim,
 
Just wanted to follow-up on our conversation the other day.  I spoke with the team and they confirmed that the syringe and rubber stopper are identical for both the EU and US presentations.   Let me know if that answers your question.
 
Kind Regards,
 
Matt
 
From: Fritz, Timothy [mailto:Timothy.Fritz@fda.hhs.gov]
Sent: Wednesday, July 11, 2012 1:40 PM
To: Gollwitzer, Matthew
Cc: Baldwin, Brenda
Subject: RE: Optaflu - Monovalent Samples for CBER testing
Sensitivity: Confidential
 
Hi Matt-
 
Novartis may ship the monovalents separately and 3 lots are OK.  I will provide information on the import permit as soon as possible.
 
Thanks,
Tim
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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From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com]
Sent: Wednesday, July 11, 2012 10:49 AM
To: Fritz, Timothy; Campbell, Karen M
Cc: Baldwin, Brenda
Subject: Optaflu - Monovalent Samples for CBER testing
Sensitivity: Confidential
Hi,
 
Karen, I am writing you in regards to Novartis’ shipment of monovalent bulk.   Brenda indicated that you need 5 lots of each strain – 20mL each.  The A/Brisbane strains are in route to Holly Springs and the A/Victoria and B/Wisconsin strains will be available for shipment mid-August.   Would you like Novartis to ship the A/Brisbane strain now, followed by the 2 other strains or would you like to receive all three monovalent strains at once?   Also, Novartis only has three lots (rather than 5) available to ship to you for testing.  Please let me know if this is acceptable.
 
Tim/Brenda, we have been shipping samples to Holly Springs first and then re-routing to CBER which takes a bit more time than if we shipped directly to CBER.  For the rest of the monovalent samples as well as the trivalent bulk samples to be shipped to CBER, do you happen to have an import permit that would cover these samples?
 
Kind Regards,
 
Matt
 
Matthew Gollwitzer
Regulatory Affairs
Novartis Vaccines and Diagnostics, Inc.
350 Mass Ave, Cambridge, MA 02139