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BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a pharmaceutical company with a market capitalization of $3 billion and strong financial health according to InvestingPro analysis, announced Thursday that the U.S. Food and Drug Administration has approved its risperidone extended-release injectable suspension, a generic version of Janssen’s Risperdal Consta.
The medication, approved in 12.5 mg, 25 mg, 37.5 mg, and 50 mg doses, is indicated for schizophrenia treatment and maintenance therapy for Bipolar I disorder, either alone or with lithium or valproate.
The product received Competitive Generic Therapy designation from the FDA, making it eligible for 180-day exclusivity. Amneal plans to launch the medication in the fourth quarter of 2025.
"This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health," said Arash Dabestani, Senior Vice President, Institutional at Amneal.
The medication requires specialized manufacturing capabilities including microsphere formulation and cold-chain production processes. According to IQVIA data cited in the company’s press release, U.S. annual sales for risperidone extended-release injectable suspension reached approximately $194 million for the 12 months ended July 2025. This new product could further boost Amneal’s already impressive 9.81% revenue growth over the last twelve months. Get deeper insights into Amneal’s growth potential with InvestingPro, which offers exclusive financial metrics and 12 additional ProTips for this stock.
Common adverse reactions reported in clinical studies include headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth.
Amneal Pharmaceuticals is a global biopharmaceutical company headquartered in Bridgewater, New Jersey, with a portfolio of over 280 pharmaceuticals. The company’s stock is currently trading near its 52-week high, reflecting strong market confidence. Discover more about Amneal’s comprehensive financial profile in the detailed Pro Research Report, available exclusively on InvestingPro.
In other recent news, Amneal Pharmaceuticals reported its Q2 2025 earnings, showcasing a stronger-than-expected performance in terms of earnings per share (EPS). The company achieved an EPS of $0.25, which exceeded the anticipated $0.17, representing a 47.06% surprise. However, revenue did not meet expectations, totaling $725 million against the forecasted $748.18 million. Despite the revenue shortfall, the earnings report contributed to a positive pre-market reaction. These recent developments highlight the company’s ability to surpass earnings forecasts, although revenue figures were slightly below projections. Investors and analysts may find these results significant when assessing Amneal Pharmaceuticals’ financial health and future performance.
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