Amneal Gains FDA Approval For Sodium Oxybate Oral Solution, Expanding Narcolepsy Care

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its sodium oxybate oral solution 500 mg/mL ANDA, a generic equivalent to Jazz Pharmaceuticals’ Xyrem®. Amneal had previously distributed an authorised generic in limited quantities, but this approval now enables broader market availability.

“This approval expands Amneal’s Affordable Medicines portfolio into a critical therapy area for patients living with narcolepsy, a rare neurological condition that affects approximately 150,000 individuals in the United States. By offering sodium oxybate, Amneal is providing patients, providers, and payers with a more affordable alternative in a therapeutic category that has historically been limited to a single manufacturer,” said Tony Rosa, Senior Vice President, Retail Affordable Medicines. 

Sodium oxybate oral solution is a central nervous system depressant indicated for patients aged seven and older with narcolepsy, specifically for treating cataplexy and excessive daytime sleepiness (EDS). Narcolepsy, a chronic neurological disorder, is marked by overwhelming daytime drowsiness, sudden sleep episodes, and cataplexy, the abrupt loss of muscle control often triggered by emotions. Sodium oxybate is widely recognised as a standard of care therapy because it helps consolidate nighttime sleep and reduce cataplexy attacks.

Common adverse reactions in adults include nausea, dizziness, vomiting, somnolence, bedwetting, and tremor, while pediatric patients may experience nausea, vomiting, headache, decreased appetite, weight loss, dizziness, enuresis, and sleepwalking. The FDA approval of Amneal’s formulation strengthens the company’s portfolio of affordable central nervous system therapies and expands treatment options for patients living with narcolepsy.