Injection for schizophrenia, Bipolar I disorder approved
The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ extended-release risperidone injectable suspension in four dosage strengths: 12.5 mg, 25 mg, 37.5 mg and 50 mg per vial. The medication references Janssen’s Risperdal Consta and is approved for the treatment of schizophrenia and as a maintenance therapy for Bipolar I disorder, either alone or alongside lithium or valproate.
The product is eligible for 180-day exclusivity under the FDA’s competitive generic therapy designation. Amneal said it plans to launch the medication in the fourth quarter of 2025.
Risperidone extended-release injectable requires specialized manufacturing, including microsphere formulation and cold-chain logistics. The most commonly reported side effects include headache, dizziness, fatigue, movement disorders and gastrointestinal symptoms.
The approval expands Amneal’s portfolio of complex and specialty medicines, particularly in the central nervous system therapeutic area. The company, headquartered in Bridgewater, New Jersey, markets more than 280 pharmaceuticals in the U.S. across generic, specialty and institutional channels.
Read more: Conexiant
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