Amneal receives u.s. fda approval for risperidone extended-release injectable suspension

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.
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