Jazz Pharmaceuticals plc’s (JAZZ) supplemental New Drug Application seeking approval for Xywav oral solution in adult patients with idiopathic hypersomnia awaits the FDA decision on August 12.Idiopathic hypersomnia is an often debilitating, neurologic sleep disorder characterized by chronic excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness) that is not caused by other medical, behavioral or psychiatric conditions.Xywav, also known as JZP-258, is a lower-sodium oxybate approved by the FDA for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.Launched in the U.S. in November 2020, Xywav registered net product sales of $15.3 million in the fourth quarter of 2020 and $75.4 million in the first quarter of 2021.Jefferies analyst David Steinberg expects the drug to achieve peak sales of $450 million in the idiopathic hypersomnia indication and over $900 million in the already approved indication of cataplexy.JAZZ closed Monday’s (Jul.26, 2021) trading at $173.26, down 0.39%.