Avadel Pharmaceuticals (AVDL) announced that yesterday, the U.S. District Court for the District of Columbia ruled in favor of the Food and Drug Administration, FDA, in a suit brought by Jazz Pharmaceuticals (JAZZ) under the Administrative Procedure Act regarding the FDA’s approval of LUMRYZ, the first and only once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy. With this ruling, the approval of LUMRYZ is upheld based on the FDA’s determination that LUMRYZ is clinically superior to Jazz’s twice-nightly oxybate products.
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