Amneal Pharmaceuticals (AMRX) announced the 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 designation. Product launch is planned for the fourth quarter of 2025.
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