Amneal Receives U.S. FDA Approval for Risperidone

 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.

Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of Bipolar I disorder.

https://www.globenewswire.com/news-release/2025/09/04/3144952/0/en/Amneal-Receives-U-S-FDA-Approval-for-Risperidone-Extended-Release-Injectable-Suspension.html