Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension.
- 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.
- According to IQVIA®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.