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Record of Telephone Conversation, October 26, 2012 - Flucelvax
Submission Type: BLA Submission ID: 125408/0 Office: OVRR
Influenza Virus Vaccine
Novartis Vaccines and Diagnostics, Inc.
Telecon Date/Time: 26-Oct-2012 04:30 PM Initiated by FDA? Yes
Author: TIMOTHY NELLE
Package Insert Changes for 20113-14 Influenza Season
FDA Participants: Timothy Nelle
Non-FDA Participants: Matthew Gollwitzer
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
During this telecon, Novartis agreed to make the following suggested edits in the FLUCELVAX package insert for next year’s influenza season.
- Under Section 8.5 Geriatric Use, the total number of subjects (currently list as “6711”) includes subjects from the site 2 of the lot consistency study which should be removed. Please change the total number of subjects to “6281”, as it is listed in Section 6.1, and adjust the “percentage (numbers)” in the same sentence as needed.
- At the top of Table 5, please indicate the total number of subjects for the “18 through 49 Years” column and the “50 through 64 Years” column.
- The residual amount of BPL was not listed correctly in the current version of the PI. It should be listed as ------(b)(4)------------ instead of “less than or equal to 0.5 mcg”.