08:42 AM EDT, 09/11/2025 (MT Newswires) -- Amneal Pharmaceuticals ( AMRX ) said Thursday that the US Food and Drug Administration has approved its generic version of sodium oxybate oral solution, referencing Jazz Pharmaceuticals' ( JAZZ ) Xyrem.

The drug is used to treat cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy, the company said.

Amneal had previously been distributing limited quantities of an authorized generic of sodium oxybate oral solution, it said.

The company said the approval expands its affordable medicines portfolio and increases patient access.

Shares of Amneal were up more than 1% in recent Thursday premarket activity.