-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy—
-- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 --
Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy.
https://finance.yahoo.com/news/avadel-pharmaceuticals-announces-fda-approval-134100767.html
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