Submission Type: BLA Submission ID: 125462/0 Office: OBRR Product:
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)
Telecon Date/Time: 15-MAR-2013 01:30 PM Initiated by FDA? Yes
Telephone Number: (204) 275-4208
1. Information Request
Author: ROBERT FISHER Telecon Summary:
BAT product stability and dating period discussion FDA Participants: Robert W. Fisher, Dorothy Scott Non-FDA Participants: Terry Kraynyk
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
FDA initiated call to Cangene to request stability testing details for lots of BAT in the SNS. FDA is trying to determine what dating period would be supported by the BAT potency data since serotype A potency appears to be the limiting factor.
FDA requested that Cangene provide:
• A list of BAT lots that would be greater than 48 months at the time of product licensure including the stability testing schedule and next time point of testing.
• The addition of Serotype A potency testing to all lots according to the time points of the regular stability program. FDA indicated that depending on the stability (potency) profile the expanded testing might be revisited in the future
• Provide PMC wording to the agency to capture the addition of the Serotype A potency testing for all lots according to the time points of the regular stability program.