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 ...
Avadel Obtains FDA Nod for Label Expansion of Narcolepsy Drug Lumryz
The FDA approves AVDL's Lumryz for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged seven ...
clinicaladvisor.com1d
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 ...
Medscape2d
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 ...
ENDPOINTS NEWS2d
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 ...
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 ...