Amneal Pharmaceuticals Inc. has announced the U.S. FDA approval of its sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA), which is a generic version referencing Jazz Pharmaceuticals' Xyrem®. This approval marks a significant expansion of Amneal's Affordable Medicines portfolio, providing a more affordable treatment option for patients with narcolepsy, a rare neurological condition affecting approximately 150,000 individuals in the U.S. Previously, Amneal had been distributing an authorized generic of this medication in limited quantities. The approval offers a new alternative in a therapeutic category that was previously limited to a single manufacturer. Sodium oxybate is a central nervous system depressant used to treat cataplexy or excessive daytime sleepiness in patients aged 7 and older with narcolepsy.