Amneal Pharmaceuticals Inc has launched its authorized generic for Xyrem (sodium oxybate) oral solution CIII for narcolepsy patients in the United States.
Sodium oxybate oral solution, 0.5 g/mL, is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients aged 7 and older with narcolepsy.
“The launch of an authorized generic version of Xyrem represents another new complex product launch as we further expand our US generics portfolio,” says Chirag Patel and Chintu Patel, co-CEOs of Amneal Pharmaceuticals, in a release.
Sodium oxybate oral solution carries a boxed warning for central nervous system depression and abuse and misuse. Taking sodium oxybate with other central nervous system depressants has been associated with trouble breathing, low blood pressure, changes in alertness, fainting, and death.
Patients on sodium oxybate should be monitored for confusion, anxiety, and suicidality. Because of these risks, sodium oxybate is available only through the Xywav and Xyrem Risk Evaluation and Mitigation Strategy. Patients must be enrolled in the Xywav and Xyrem Risk Evaluation and Mitigation Strategy to receive sodium oxybate oral solution.
Xyrem is a registered trademark of Jazz Pharmaceuticals Inc. Jazz Pharmaceuticals received US Food and Drug Administration approval for Xyrem in October 2002 as the first and only treatment for cataplexy in patients with narcolepsy. It received an expanded indication for the treatment of excessive daytime sleepiness in patients with narcolepsy in November 2005.
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