Amneal Pharmaceuticals announces FDA approval of prednisolone acetate ophthalmic suspension, with commercial launch set for Q3 2025.
Quiver AI Summary
Amneal Pharmaceuticals has announced the FDA approval of its prednisolone acetate ophthalmic suspension, a 1% sterile topical anti-inflammatory treatment intended for steroid-responsive ocular inflammation. The product is set to launch in the third quarter of 2025 and is a key addition to the company's Affordable Medicines portfolio, which aims to provide broader access to high-quality treatments in the U.S. healthcare system. The approval highlights Amneal's research and development and manufacturing capabilities. The suspension's common side effects include elevated intraocular pressure, potential glaucoma, and other vision-related issues. In the past year, annual sales for this product were approximately $201 million.
Potential Positives
- FDA approval of prednisolone acetate ophthalmic suspension demonstrates Amneal's strong R&D capabilities and successful navigation of complex product development.
- The planned launch of the product in Q3 2025 positions Amneal to capture a share of the approximately $201 million annual market for this medication.
- The expansion of the Affordable Medicines portfolio supports broader access to high-quality treatments, reflecting Amneal's commitment to improving U.S. healthcare.
Potential Negatives
- Potential adverse reactions associated with the product, including elevation of intraocular pressure, possible development of glaucoma, optic nerve damage, cataract formation, and delayed wound healing, could raise concerns about safety and liability.
- The mention of a planned launch in the third quarter of 2025 implies a significant delay before the product becomes available, which may lead to missed revenue opportunities in a competitive market.
- Forward-looking statements highlight uncertainty regarding the company’s operational plans and financial forecasts, which could affect investor confidence and stock performance.
FAQ
What new product did Amneal Pharmaceuticals receive FDA approval for?
Amneal Pharmaceuticals received FDA approval for prednisolone acetate ophthalmic suspension, 1% sterile.
When is the launch date for the approved product?
The commercial launch is planned for the third quarter of 2025.
What is the primary use of prednisolone acetate ophthalmic suspension?
This product is indicated for treating steroid-responsive ocular inflammation.
What are the common side effects of this ophthalmic suspension?
Common side effects include elevated intraocular pressure and delayed wound healing.
How does Amneal contribute to the Affordable Medicines segment?
Amneal's Affordable Medicines segment supports access to high-quality treatments through a diverse pipeline of complex products.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
- Key complex product approval in the Affordable Medicines segment this year
- Commercial 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 Amneal
Amneal 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
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Cautionary Statement on Forward-Looking Statements
Certain 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.
Investor Contact
Anthony DiMeo
VP, Investor Relations
[email protected]
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
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