Amneal Pharmaceuticals has received FDA approval for its Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution 0.01%, marking the company’s latest addition to its Affordable Medicines portfolio. The generic product is approved in 2.5 mL, 5 mL, and 7.5 mL volumes and is a therapeutic equivalent to LUMIGAN, used for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension..

Amneal Pharmaceuticals 已获得其0.01%比马前列素滴眼液的简略新药申请（ANDA）的FDA批准，这标志着该公司在其“可负担药物”产品组合中的最新成员。该仿制药已批准以2.5毫升、5毫升和7.5毫升的规格上市，是LUMIGAN的治疗等效替代品，用于降低开角型青光眼或高眼压症患者的高眼内压（IOP）。

FDA Greenlights Generic Version of LUMIGAN

FDA批准了LUMIGAN的仿制药版本

The approval from the U.S. Food and Drug Administration (FDA) enables Amneal to manufacture and market bimatoprost ophthalmic solution 0.01%, a prostaglandin analog indicated to reduce IOP. The decision was granted through the Abbreviated New Drug Application (ANDA) pathway, which facilitates the approval of generic versions of already approved drugs by eliminating the need for extensive clinical and preclinical trials..

美国食品药品监督管理局 (FDA) 的批准使得 Amneal 能够生产和销售 0.01% 比马前列素滴眼液，这是一种用于降低眼内压的前列腺素类似物。该决定通过简化新药申请 (ANDA) 途径获得批准，该途径通过免除对已批准药物的仿制药版本进行广泛临床和临床前试验的需求来促进其审批。

Addressing Access to Glaucoma Therapies Through Generic Alternatives

通过通用替代品解决青光眼治疗的可及性问题

“We are pleased to add another key ophthalmic therapy to our Affordable Medicines portfolio,” said Srinivas Kone, PhD, Senior Vice President and Chief Scientific Officer at Amneal.

“我们很高兴在我们的平价药品组合中再增加一种重要的眼科疗法，”Amneal公司的高级副总裁兼首席科学官Srinivas Kone博士表示。

“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.”.

“随着青光眼的患病率持续上升，尤其是在老龄化人口中，患者和医疗服务提供者能够负担得起诸如比马前列素等有效治疗药物的获取至关重要。这是我们今年最新的复杂新产品批准，也是我们平价药品部门的重要增长动力。”

Amneal’s Affordable Medicines segment spans multiple complex product categories, including injectables and biosimilars, with a focus on expanding access to essential treatments across diverse therapeutic areas.

Amneal的平价药品部门涵盖多个复杂的产品类别，包括注射剂和生物仿制药，重点是扩大在不同治疗领域中对基本治疗的获取途径。

The bimatoprost approval follows another key ophthalmic development for Amneal. In June 2025, the FDA also approved the company’s prednisolone acetate ophthalmic suspension, a topical anti-inflammatory agent used in the treatment of steroid-responsive ocular inflammation, referencing Pred Forte. The commercial launch of this product in the U.S.

比马前列素的获批是继Amneal另一项眼科领域关键进展之后的成果。2025年6月，FDA还批准了该公司的醋酸泼尼松龙眼科混悬液，这是一种用于治疗类固醇反应性眼部炎症的局部抗炎药，参照药物为Pred Forte。该产品在美国的商业发布也已启动。

is expected in Q3 2025..

预计在2025年第三季度。