Approval Letter Other 218772 (Jan 1, 2025)
This FDA letter, an 'Other Action Letter' for NDA 218772, informs the applicant of outstanding product quality deficiencies and outlines requirements for resubmission. It reserves comments on draft labeling and carton/container labeling until the application is otherwise approvable/adequate. The letter also addresses the proprietary name, Arbli, which is conditionally acceptable, and provides detailed instructions for a mandatory safety update to be included with the resubmission. The applicant is required to resubmit or take other actions within one year, fully addressing all identified deficiencies, and is reminded that the product cannot be legally marketed until approved.
