Amneal Receives U.S. FDA Approval of Sodium Oxybate Oral Solution

BRIDGEWATER, N.J, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of Amneal’s sodium oxybate oral solution 500 mg/mL Abbreviated New Drug Application (ANDA) which references Jazz Pharmaceuticals’ Xyrem^®. Amneal had previously been distributing an authorized generic of sodium oxybate oral solution in limited quantities.

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