The FDA has granted tentative approval to Lumryz, a once-at-bedtime oral treatment for excessive daytime sleepiness or cataplexy in adults with narcolepsy, Avadel Pharmaceuticals announced in a press release.
According to the biopharmaceutical company, final approval of Lumryz (sodium oxybate, Avadel) is pending disposition of a patent, which is currently listed in the FDA’s Orange Book. The extended-release oral suspension has met all required quality, safety and efficacy standards, the company said in the release.
“We have reached a critical milestone, as tentative approval