AVDL - Avadel requests final FDA approval for Lumyrz in narcolepsy

• Avadel Pharmaceuticals ( NASDAQ: AVDL ) has submitted an amendment to the FDA requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
• This submission follows a unanimous 3-0 panel decision by the United States Court of Appeals for the Federal Court on February 24, affirming the previous ruling from the U.S. District Court of Delaware, ordering Jazz Pharmaceuticals to delist its U.S. Patent No. 8,731,963 (“REMS Patent”) from FDA’s Orange Book. Jazz submitted its request to delist the REMS Patent to FDA on February 28.
• Following Jazz’ request to delist the REMS Patent on February 28, 2023, Avadel filed a minor amendment with the FDA on March 1, 2023, removing its certification to the REMS Patent and requesting final approval of LUMRYZ.

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