Avadel wins FDA approval for narcolepsy drug Lumryz
US FDA expands use of Avadel's sleep disorder drug to ages 7 and up
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for popular treatments from Jazz Pharmaceuticals.
Avadel Obtains FDA Nod for Label Expansion of Narcolepsy Drug Lumryz
Avadel Pharmaceuticals plc AVDL announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz. The drug is now approved in the United States for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy.
Avadel's narcolepsy drug Lumryz gets USFDA approval for pediatric use
Avadel's drug contains a central nervous system depressant drug called sodium oxybate, which helps increase the amount of time someone spends in deep sleep.
US FDA expands approval for Avadel's sleep disorder drug
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and older, broadening its use and heating up competition for widely used treatments from Jazz Pharma.
Avadel Gets Expanded FDA OK of Lumryz for Use in Children
Avadel Pharmaceuticals has won expanded Food and Drug Administration approval of its narcolepsy drug Lumryz for use in children. Avadel on Thursday said the FDA nod covers Lumryz for the treatment of cataplexy, or excessive daytime sleepiness, in children ages seven and older with narcolepsy, a chronic sleep disorder.
FDA ex­pands la­bel for Avadel's nar­colep­sy drug in­to chil­dren
Avadel Pharmaceuticals said its once-nightly narcolepsy drug Lumryz can now be used to treat children older than 7 years of age. The Thursday approval of the
Avadel wins FDA approval for narcolepsy drug Lumryz in children
The expanded approval intensifies the rivalry with Jazz Pharmaceuticals, which has previously attempted to block Lumryz’s path to market.
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