“Risperidone extended-release injectable suspension requires advanced capabilities—such as microsphere formulation and cold-chain manufacturing,” noted Arash Dabestani, Pharm.D., Senior Vice President, Institutional.

Amneal Pharmaceuticals announced the US Food and Drug Administration approval of risperidone extended-release injectable suspension (12.5 mg/vial, 25 mg/vial, 37.5 mg/vial, 50 mg/vial), which references Janssen’s Risperdal Consta. The product is eligible for 180-day exclusivity under the US Food and Drug Administration Competitive Generic Therapy designation, with a US launch planned for the fourth quarter of 2025.

Risperidone extended-release injectable suspension, an atypical antipsychotic, is approved to treat schizophrenia. The therapy may be used as monotherapy or as adjunctive treatment with lithium or valproate for maintenance treatment of Bipolar I disorder.  

The most reported adverse reactions in clinical studies were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increased, pain in extremity, and dry mouth. Complete prescribing information is available in the package insert.

Source: Amneal Pharmaceuticals