Item 8.01 Other Events.

On October 15, 2021, Avadel Pharmaceuticals plc (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") notified the Company that its review of the new drug application ("NDA") for the Company's lead product candidate, FT218, was still ongoing. In February 2021, the FDA accepted Avadel's NDA for FT218 and assigned a target action date of October 15, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.





Item 9.01. Exhibits




(d) Exhibits



  99.1     Press release issued by the Company on October 15, 2021.

104 Cover Page Interactive Data File (embedded with the Inline XBRL document).

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