Business
Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%
Important ophthalmic treatment for patients and expected to be a key growth driver for Amneal’s Affordable Medicines segment BRIDGEWATER, N.J., Sept. 23, 2025
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"Important ophthalmic treatment for patients and expected to be a key growth driver for Amneal’s Affordable Medicines segment\nBRIDGEWATER, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company. Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. “We are pleased to add another key ophthalmic therapy to our Affordable Medicines portfolio,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “As the prevalence of glaucoma continues to rise, particularly among the aging population, it is critical that patients and providers have affordable access to effective treatments such as bimatoprost. This represents our most recent complex new product approval this year and an important growth driver for our Affordable Medicines segment.” The most common adverse reaction associated with bimatoprost ophthalmic solution 0.01% is conjunctival hyperemia. For prescribing information, see package insert here. According to IQVIA® U.S. annual sales for bimatoprost ophthalmic solution 0.01% for the 12 months ended July 2025 were approximately $685 million. Note: LUMIGAN® is a registered trademark of Allergan, Inc., an AbbVie company. 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 Co...