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BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) has received U.S. Food and Drug Administration approval for prednisolone acetate ophthalmic suspension, 1% sterile, the company announced Thursday. The company, which generated revenue of $2.83 billion in the last twelve months and maintains a market capitalization of $2.44 billion, has shown strong revenue growth of ~13% year-over-year.
The product, which references Pred Forte by Allergan (an AbbVie company), is a topical anti-inflammatory agent used to treat steroid-responsive ocular inflammation. According to InvestingPro analysis, Amneal’s financial health score is rated as "GREAT," suggesting strong operational performance. Commercial launch is planned for the third quarter of 2025, with analysts expecting the company to return to profitability this year.
"Our Affordable Medicines portfolio continues to grow with a strong and diverse pipeline that supports broader access to high-quality treatments across the U.S. healthcare system," said Andy Boyer, Executive Vice President and Chief Commercial Officer, Affordable Medicines.
According to IQVIA data cited in the company statement, U.S. annual sales for prednisolone acetate ophthalmic suspension reached approximately $201 million for the 12 months ended April 2025.
The most commonly reported adverse reactions in clinical studies were elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
Amneal Pharmaceuticals, headquartered in Bridgewater, New Jersey, develops, manufactures, and distributes over 280 pharmaceutical products primarily within the United States. The company operates across three segments: Affordable Medicines, Specialty pharmaceuticals, and AvKARE, which distributes products to federal government, retail, and institutional markets. For deeper insights into Amneal’s financial health and growth prospects, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find detailed research reports and expert commentary.
This information is based on a press release statement issued by Amneal Pharmaceuticals.
In other recent news, Amneal Pharmaceuticals reported its first-quarter 2025 earnings, surpassing analysts’ expectations with an adjusted EPS of $0.21, compared to the forecasted $0.15. Revenue for the quarter was $695 million, slightly below the anticipated $726.49 million. The company’s gross margin improved to 43.1%, up 120 basis points year-over-year, reflecting strong profit margins and strategic growth initiatives. Additionally, Amneal announced that the FDA has approved its Brekiya autoinjector, marking it as the first and only DHE autoinjector for treating migraines and cluster headaches in adults. This approval addresses a significant need for alternative treatment options for patients who do not respond to oral therapies. Goldman Sachs initiated coverage on Amneal Pharmaceuticals with a Neutral rating, citing the company’s strong product pipeline as a key driver of anticipated growth, particularly in the generics and branded segments. The analysts noted that Amneal’s generics segment is expected to exceed consensus estimates by 13% in fiscal year 2027, driven by biosimilar and sterile injectable launches. They also highlighted the potential for the company’s revenue and EBITDA estimates to expand further over time.
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