FDA Gives Tentative Approval to LUMRYZ, Avadel’s Narcolepsy Drug
The US Food and Drug Administration has granted tentative approval to LUMRYZ, also known as FT218, by Avadel Pharmaceuticals plc.
The US Food and Drug Administration has granted tentative approval to LUMRYZ, also known as FT218, by Avadel Pharmaceuticals plc.
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
During the manufacturing facility inspection, the FDA obtained additional information regarding the silicone-based foam used in a device outside the United States that failed one safety test for the release of VOCs.
Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The Gazette: Peggy Waters reported being diagnosed with sleep apnea in 2014 while working at the university.
Lifesaving equipment is being denied payment because of rigid criteria in local coverage determinations and existing coverage provided by CMS is not reflective of rapidly evolving technology in the field.
Kevin Rumph Jr. used his government-issued purchase card to make unauthorized purchases of CPAP supplies from a supplier in Alabama.
The commission investigation has found that for several years, this “pay-for-delay” agreement eliminated Teva as a competitor and allowed Cephalon to continue charging high prices even if the main modafinil patent had long expired.
An investigation found the train engineer had undiagnosed sleep apnea, and a National Transportation Safety Board investigation faulted NJ Transit for not following its sleep apnea testing guidelines, reports NBC 4 New York.