Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension

– Fluorometholone Ophthalmic Suspension, USP, 0.1%

– Product has 180-day competitive generic therapy exclusivity

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension. The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines.

FML^® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

“We are starting the new year with the launch of another complex high-value product, which will help drive our continued growth,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Generics. “Ophthalmic products represent a less crowded and more durable category, and we continue to expand our portfolio of affordable medicines.”

Adverse drug events reported with the use of fluorometholone ophthalmic suspension 0.1% include short term inflammatory eye reactions such as eye and eyelid swelling, redness, burning eye pain, itchy eyes; and long-term use effects including elevation of intraocular pressure (IOP) with possible development of glaucoma, infrequent optic nerve damage, cataract formation, vision problems, and delayed eye wound healing. For full prescribing information, see package insert located here.

According to IQVIA^®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.

About Amneal

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 270 pharmaceutical products, primarily within the United States. In its Generics 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, with a pipeline focused on unmet needs. 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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Contacts

Investor

Anthony DiMeo

Head of Investor Relations

[email protected]