SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
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Ordinary Shares, nominal value $0.01 per share**
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Emerging growth company
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|Item 8.01||Other Events.|
On March 1, 2023, Avadel Pharmaceuticals plc submitted an amendment to its New Drug Application to the U.S. Food and Drug Administration (“FDA”) requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. The submission follows the FDA submission by Jazz Pharmaceuticals of February 28, 2023, requesting delisting of U.S. Patent No. 8,731,963 from FDA’s Orange Book pursuant to the United States Court of Appeals for the Federal Court decision of February 24, 2023, affirming the previous ruling from the United States District Court for the District of Delaware, ordering such delisting.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: March 2, 2023||AVADEL PHARMACEUTICALS PLC|
|By:||/s/ Jerad G. Seurer|
|Name:||Jerad G. Seurer|
|Title:||General Counsel & Corporate Secretary|