Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension

(NASDAQ:AMRX) BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025.