
Record of Telephone Conversation, August 10, 2012 am - 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-Aug-2012 12:00 AM        Initiated by FDA? Yes

Telephone Number:

Communication Categorie(s):

1. Advice

 

Author: TIMOTHY NELLE

Telecon Summary:

Suitability of "EU" monovalent bulks for reagent qualification

FDA Participants: Matthew Gollwitzer

Non-FDA Participants: None

Trans-BLA Group: No

 

Related STNs: None

Related PMCs: None

Telecon Body:

 

On August 8, 2012, Novartis submitted the following question:

In an email from Dr. Brenda Baldwin, CBER is requesting 3 lots of each monovalent strain, 20mL each, for reagent qualification.   These samples are currently available for shipment to your attention.  The monovalent samples currently available are considered Optaflu “EU” samples.  Novartis is proposing to submit Optaflu “EU” samples because they are currently available and suitable for the intended use of reagent qualification because the manufacturing process and composition of the “EU” and “US” monobulks are identical. 

 

Novartis is proposing to submit the “EU” monobulks because they are readily available to initiate your reagent qualification.  The “US” monobulks will not be available until the coming weeks. 

 

The proposed strains and lot numbers are outlined below:

 



Monobulk Strain                                Lots Numbers 



A/Brisbane10/2010 EU                          ---------(b)(4)-------------------- 


A/Victoria/361/2011 EU                        ---------(b)(4)-------------------- 

 
B/Wisconsin/1/2010 EU                         ---------(b)(4)-------------------- 



 

Please let us know if this is acceptable to you and Novartis will begin initiating shipment of monovalent bulk to you immediately.

 

On August 10, 2012, CBER stated that it was acceptable to submit the EU monovalent bulks samples for reagent qualification.