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Amneal Receives U.S. FDA Approval for Prednisolone Acetate Ophthalmic Suspension

1. Amneal received FDA approval for prednisolone acetate ophthalmic suspension. 2. The product launch is scheduled for Q3 2025. 3. Annual sales for the product were approximately $201 million as of April 2025. 4. The approval emphasizes Amneal's R&D and manufacturing strength. 5. The product helps treat steroid-responsive ocular inflammation.

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FAQ

Why Bullish?

The FDA approval indicates strong potential revenue growth. Historical precedents show stock price increases post-approval.

How important is it?

FDA approvals significantly impact stock prices and market perception. Given the financial metrics, this announcement is crucial for AMRX.

Why Long Term?

Sales from the new product will contribute to revenue for years. The sustained demand for ocular products supports ongoing growth.

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June 12, 2025 08:00 ET  | Source: Amneal Pharmaceuticals LLC Key complex product approval in the Affordable Medicines segment this yearCommercial launch planned for third quarter of 2025 BRIDGEWATER, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of prednisolone acetate ophthalmic suspension, 1% sterile which references Pred Forte®. Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. Launch of this product is planned for the third quarter of 2025. Prednisolone acetate ophthalmic suspension, USP 1% is a sterile, topical anti-inflammatory agent for ophthalmic use and is indicated for treating steroid-responsive ocular inflammation. “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. “The approval of prednisolone acetate ophthalmic suspension—a complex product to develop and manufacture—highlights the depth of our R&D capabilities and the strength of our manufacturing and supply operations.” The most commonly reported adverse reactions for prednisolone acetate ophthalmic suspension in clinical studies were elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. For prescribing information, see package insert here. According to IQVIA® U.S. annual sales for prednisolone acetate ophthalmic suspension for the 12 months ended April 2025 were approximately $201 million. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

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