  


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