Revance Therapeutics, Inc. responds to the public disclosure of its Form 483 pursuant to a Freedom of Information Act (FOIA) request that was directed to the FDA. The Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under FDA review and the company continues to anticipate FDA approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines in 2021. Revance notes that the issuance of a Form 483 following the conclusion of an on-site inspection is not uncommon. A Form 483 lists observations made by FDA representatives during the inspection of a facility. A Form 483 does not constitute a final agency determination. Revance provided its response to the Form 483 in July 2021 following a pre-approval inspection and is currently awaiting the FDAs decision on its BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines. The company remains confident in the quality of its BLA submission and continues to anticipate FDA approval in 2021.