Avadel Seeks Final FDA Approval For Lumryz For Treatment Of Cataplexy In Adults With Narcolepsy

(RTTNews) - Avadel Pharmaceuticals plc. (AVDL) said Thursday it has submitted an amendment to the U.S. Food and Drug Administration requesting final approval for Lumryz for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

The 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 United States District Court for the District of Delaware, ordering Jazz Pharmaceuticals to delist its U.S. Patent No. 8,731,963 from FDA's Orange Book.

Jazz submitted its request to delist the REMS Patent to FDA on February 28.

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