
Record of Telephone Conversation, July 9, 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: 09-Jul-2012 04:52 PM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: BRENDA BALDWIN

Telecon Summary:

Seed virus submission information

FDA Participants: Brenda Baldwin

Non-FDA Participants: Matthew Gollwitzer

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

E-mail Body:

From: Baldwin, Brenda [mailto:Brenda.Baldwin@fda.hhs.gov] 
Sent: Monday, July 09, 2012 4:52 PM
To: Gollwitzer, Matthew
Subject: 125408 
Sensitivity: Confidential

 

Hi Matt,

 

Regarding the questions you raised in your July 6, 2012 e-mail, I have a response to 2 of the questions thus far and a need for clarification from 1 of your questions:

 

The package insert will not be further revised until after you submit your revised package insert. You do not need to apply for a permit for sending virus to CBER, but should include the attached permit in the package. The package should be sent to:   Dr. Vladimir Lugovtsev

                        Laboratory of Respiratory Viruses

                        CBER/FDA

                        8800 Rockville Pike,

                        Bldg. 29A, Room 2B17

                        HFM-463

                        Bethesda, MD 20892, USA

Please clarify if you are sending the trivalent bulk from the 2011/2012 formulation or the 2012/2013 formulation, or if you are sending monovalent strains for the 2012/2013 formulation.

 

Regards,

Brenda



From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com] 
Sent: Thursday, July 12, 2012 1:04 PM
To: Baldwin, Brenda
Subject: RE: 125408 
Sensitivity: Confidential

Hi Brenda,

 

Thank you for sending the permit and information below.  Also to answer your question, we will be sending trivalent and monovalent strains for the 2012/2013 formulation.

 

Kind Regards,

 

Matt



 

From: Baldwin, Brenda [mailto:Brenda.Baldwin@fda.hhs.gov] 
Sent: Thursday, July 12, 2012 1:58 PM
To: Gollwitzer, Matthew
Subject: RE: 125408 
Sensitivity: Confidential

 

Hi Matt,

 

I understand that the monovalents will be sent in soon.  Do you have an estimated date when the trivalent bulk will be sent to CBER?

 

Regards,

Brenda

 



From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com] 
Sent: Friday, July 13, 2012 7:22 AM
To: Baldwin, Brenda
Subject: RE: 125408 
Sensitivity: Confidential

Hi Brenda,

 

Just following up on yesterday’s email, it looks like one lot of trivalent bulk will be ready late August followed by the other two lots in early September.  I’m not sure if the manufacture can be expedited, but let me know if you foresee any issues with the timeline.

 

Kind Regards,

 

Matt



From: Gollwitzer, Matthew [mailto:matthew.gollwitzer@novartis.com] 
Sent: Wednesday, July 18, 2012 3:21 PM
To: Baldwin, Brenda; Fritz, Timothy
Subject: 125408 - USDA permit for Seed Virus Shipment?
Sensitivity: Confidential

Hello,

 

A couple weeks back you sent me a CDC permit for the shipment of the seed virus.  Would you happen to have a USDA permit as well?  We tried to ship the seed virus and the courier refused to ship because we didn’t have a USDA permit.    I have applied for USDA permits in the past (for delivery of FLUAD to US) and it took 6-8 weeks to obtain it.   Please let me know when you get a chance.  If you have one, we will try to reship next Monday.

 

Kind Regards,

 

Matt

 



From: Fritz, Timothy 
Sent: Thursday, July 19, 2012 10:55 AM
To: 'Gollwitzer, Matthew'
Cc: Baldwin, Brenda
Subject: RE: 125408 - USDA permit for Seed Virus Shipment?
Sensitivity: Confidential

Hi Matt-

 

It is not clear to us that a USDA permit is required (since the seeds are grown in MDCK cells) and we do not have the appropriate permit available.  Our best recommendation would be to try to use a different courier.  Please keep us informed of the outcome.

 

Thanks,

Tim

 