FDA to Initiate Pre-Approval Inspection of DAXI Manufacturing Facility

Morgan Petronelli, Associate Editor

Revance provides an update on the approval process for its injectable daxibotulinumtoxinA (DAXI) for the treatment of glabellar lines.

Revance Therapeutics announced the FDA will initiate its pre-approval inspection of the company’s daxibotulinumtoxinA (DAXI, Revance Therapeutics) manufacturing facility by the end of June 2021.1

The company reports that in November 2020, the FDA advised Revance that it was deferring a decision on the Biologics License Application (BLA) for DAXI because the pre-approval manufacturing facility inspection could not be conducted due to COVID-19 pandemic-related travel restrictions.

Revance is seeking approval of DAXI for injection for the treatment of moderate to severe glabellar lines (GL).

Reference:

1. Revance provides update on daxibotulinumtoxina for injection pre-approval inspection. BioSpace. Accessed June 4, 2021. https://www.biospace.com/article/revance-provides-update-on-daxibotulinumtoxina-for-injection-pre-approval-inspection/