Amneal Pharmaceuticals receives FDA approval of sodium oxybate oral solution

Amneal Pharmaceuticals (AMRX) announced the U.S. Food and Drug Administration approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities. Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Narcolepsy is characterized by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions and sodium oxybate is considered a standard of care therapy in narcolepsy due to its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes.