- \n
- Approval underscores Amneal\u2019s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026\u00a0<\/em><\/li>\n<\/ul>\n
BRIDGEWATER, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (\u201cAmneal\u201d or the \u201cCompany\u201d) (NASDAQ: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company\u2019s cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation supplied in single-use vials. The product is the generic equivalent of RESTASIS\u00ae<\/sup> (cyclosporine ophthalmic emulsion) 0.05%, a registered trademark of Allergan, an AbbVie company.<\/p>\n
\u201cDry eye disease affects millions of adults in the United States and can significantly impact their quality of life,\u201d said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer \u2013 Affordable Medicines. \u201cWe are proud to bring another difficult-to-manufacture ophthalmic product to market, reinforcing Amneal\u2019s strong execution in complex formulations and our expanding leadership in ophthalmology within the Affordable Medicines segment. Cyclosporine joins a series of recent approvals across inhalation, injectable, and ophthalmic categories, underscoring Amneal\u2019s strong execution in high-quality sterile manufacturing.\u201d<\/p>\n
Cyclosporine ophthalmic emulsion 0.05% is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with dry eye syndrome. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.<\/p>\n
The most common adverse reaction associated with cyclosporine ophthalmic emulsion 0.05% was ocular burning. Please see full Prescribing Information here<\/a>.<\/p>\n
According to IQVIA\u00ae<\/sup> U.S. annual sales for cyclosporine ophthalmic emulsion 0.05% in sterile, preservative-free single-use vials for the 12 months ended September 2025 were approximately $2.0 billion.<\/p>\n
Note: RESTASIS\u00ae<\/sup>\u00a0is a registered trademark of Allergan, an AbbVie company.<\/p>\n
About Amneal<\/strong>
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 290 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\u00a0www.amneal.com<\/a> and follow us on LinkedIn<\/a>.<\/p>\nCautionary Statement on Forward-Looking Statements<\/strong>
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\u2019s 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 \u201cplans,\u201d \u201cexpects,\u201d \u201cwill,\u201d \u201canticipates,\u201d \u201cestimates,\u201d 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\u2019s filings with the Securities and Exchange Commission, including under Item 1A, \u201cRisk Factors\u201d in the Company\u2019s 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.<\/p>\nInvestor Contact <\/strong>
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com<\/a><\/p>\n
![\"\"](\"https:\/\/ml.globenewswire.com\/media\/NjE5YzRkOTUtMGUyOC00OTZhLTgyNmMtNzI3ZTk5MTc2YjEyLTEyMDIyOTAtMjAyNS0xMi0wMS1lbg==\/tiny\/Amneal-Pharmaceuticals-LLC.png\")
\n <\/div>\n","protected":false},"excerpt":{"rendered":"