Amneal Receives U.S. FDA Approval for Sodium Oxybate Oral Solution
Friday, September 12, 2025
Amneal Pharmaceuticals, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its sodium oxybate oral solution 500 mg/mL, through an Abbreviated New Drug Application (ANDA). The product references Jazz Pharmaceuticals’ Xyrem®. Amneal had earlier supplied an authorised generic version of this medicine in limited quantities.
Sodium oxybate oral solution is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness in patients aged seven years and above with narcolepsy. The condition is marked by excessive daytime sleepiness, sudden sleep attacks, and cataplexy, a sudden loss of muscle control often triggered by emotions. Sodium oxybate is recognised as a standard treatment, as it helps consolidate night-time sleep and significantly reduces cataplexy episodes.
The approval strengthens Amneal’s Affordable Medicines portfolio by adding a treatment option for narcolepsy, a rare neurological condition that affects around 150,000 people in the United States. The product is expected to provide patients, healthcare providers, and payers with a more cost-effective alternative in a therapy area previously dominated by a single manufacturer.
The most common side effects reported in adults include nausea, dizziness, vomiting, sleepiness, bedwetting, and tremor. In children, the most frequent side effects were nausea, bedwetting, vomiting, headache, weight loss, decreased appetite, dizziness, and sleepwalking.
Source: globenewswire.com
