narcolepsy, FDA and Avadel
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.
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.
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 OKs Once-Nightly Lumryz for Children with Narcolepsy
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.
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 Pharma's SNDA For Lumryz Gets FDA Approval
Biopharmaceutical company Avadel Pharmaceuticals plc (AVDL), Thursday announced that the U.S. Food and Drug Administration (FDA) has
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
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.
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Lumryz Approval Expanded to Include Pediatric Narcolepsy
Lumryz is an extended-release formulation of sodium oxybate, a central nervous system (CNS) depressant. Its therapeutic effects are believed to be mediated through GABA B actions at noradrenergic and ...
Jazz Pharmaceuticals: Unexpected Wins Improve The Long-Term Outlook
Shares of Jazz Pharmaceuticals are trading only slightly higher in the last few weeks despite two unexpected wins. Explore ...
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Avadel Pharma Reports Patient Preference For Lumryz In RESTORE Study
(RTTNews) - Avadel Pharmaceuticals plc (AVDL), Tuesday revealed that 94 percent of patients in RESTORE study with narcolepsy preferred the once-nightly regimen of Lumryz over twice-nightly Oxybate ...
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Avadel Pharmaceuticals plc (AVDL)
“We are proud to be included in the widely – 11 accepted abstracts, including new data reiterating satisfaction, preference and clinical benefit of LUMRYZ – – Presentations highlight ...