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3 ημέρες πριν · LUMRYZ was approved by the FDA for use in the treatment of cataplexy or excessive daytime sleepiness in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse ...
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2 ημέρες πριν · Paediatric patients with narcolepsy will now have access to Avadel’s Lumryz (sodium oxybate) after the US Food and Drug Administration (FDA) approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness, called cataplexy, or excessive daytime sleepiness (EDS) in ...
2 ημέρες πριν · LUMRYZ was approved by the FDA for use in the treatment of cataplexy or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity ...
3 ημέρες πριν · Lumryz is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness in children as young as 7 years with narcolepsy.
3 ημέρες πριν · The US Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for sodium oxybate (LUMRYZ) to treat cataplexy and excessive daytime sleepiness in children aged ≥ 7 years with narcolepsy. 1. Announced by Avadel Pharmaceuticals on October 17, 2024, this indication would expand the availability of oxybate to children.
17 Ιαν 2020 · In August 2019, pitolisant was approved by the US Food and Drug Administration (FDA) for treatment of EDS in adult patients with narcolepsy; the recommended dose range is 17.8–35.6 mg/day [13, 14]. Table 1 summarises dose titration recommendations.
25 Ιουν 2024 · On June 24, 2024, Harmony Biosciences announced FDA approval of its supplemental new drug application (sNDA) for pitolisant (WAKIX) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients aged 6 and older with narcolepsy.
