ITEM 8.01 OTHER EVENTS OnOctober 15, 2021 ,Revance Therapeutics, Inc. (the "Company") announced that theUnited States (U.S.) Food and Drug Administration (the "FDA") has issued a Complete Response Letter ("CRL") regarding the Company's Biologics License Application (the "BLA") for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines. In a communication received by the Company onOctober 15, 2021 , the FDA indicated it is unable to approve the BLA in its present form and indicated that there are deficiencies related to theFDA's onsite inspection at the Company's manufacturing facility. The Company plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised.
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