(RTTNews) - Amneal Pharmaceuticals, Inc. (AMRX) Thursday said that the U.S. Food and Drug Administration (FDA) has approved its sodium oxybate oral solution which references Jazz Pharmaceutical's Xyrem.
Sodium oxybate oral solution is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in individuals aged 7 years and older with narcolepsy.
Amneal had previously been distributing an approved generic of sodium oxybate oral solution in limited quantities.
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