FDA approves abbreviated new drug application from Amneal Pharmaceuticals for bimatoprost ophthalmic solution 0.01%

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals' Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01% (2.5 mL, 5 mL and 7.5 mL).¹

An ANDA is a submission to the FDA that seeks approval to market a generic version of an already-approved brand-name drug, relying on the already approved medicine to reduce the need for extensive preclinical and clinical human trials.

Bimatoprost ophthalmic solution 0.01% is a prostaglandin analog for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension and is the generic equivalent of LUMIGAN.

Srinivas Kone, PhD, senior vice president and chief scientific officer, stated in a press release from the company, “We are pleased to add another key ophthalmic therapy to our Affordable Medicines portfolio. 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 Affordable Medicines segment of Amneal expands across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars.

In June 2025, Amneal also announced that the FDA had approved prednisolone acetate ophthalmic suspension, a sterile, topical anti-inflammatory agent for ophthalmic use that is indicated for treating steroid-responsive ocular inflammation, referencing Pred Forte. The US commercial launch of prednisolone acetate ophthalmic suspension is planned for Q3 of 2025.²

References:

1. Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%. Published September 23, 2025. Accessed September 23, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S--FDA-Approval-for-Bimatoprost-Ophthalmic-Solution-0-01/default.aspx

2. Harp MD. FDA approves prednisolone acetate ophthalmic suspension for treating steroid-responsive ocular inflammation. Published June 12, 2025. Accessed September 23, 2025. https://www.ophthalmologytimes.com/view/fda-approves-prednisolone-acetate-ophthalmic-suspension-for-treating-steroid-responsive-ocular-inflammation