Lupin Limited has officially launched loteprednol etabonate ophthalmic suspension, 0.5%, in the United States. This launch expands the company’s ophthalmic portfolio and brings a new generic alternative to an established corticosteroid therapy.

鲁宾有限公司已在美国正式推出0.5%的洛特泼尼松乙酸酯眼科混悬液。此次上市扩大了公司的眼科产品组合，并为一种已确立的皮质类固醇疗法带来了新的仿制替代品。

Bioequivalent to Lotemax Ophthalmic Suspension

与Lotemax眼用混悬液生物等效

The newly launched product is bioequivalent to Bausch & Lomb’s Lotemax Ophthalmic Suspension, 0.5%, a widely prescribed corticosteroid formulation. Loteprednol etabonate ophthalmic suspension, 0.5% is indicated for the treatment of steroid-responsive inflammatory conditions affecting the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, in cases where the benefits of steroid use outweigh potential risks..

新推出的产品与博士伦公司的Lotemax眼用混悬液0.5%具有生物等效性，这是一种广泛使用的皮质类固醇配方。Loteprednol etabonate眼用混悬液0.5%适用于治疗影响睑结膜、球结膜、角膜及眼球前段的类固醇反应性炎症，在使用类固醇的益处大于潜在风险的情况下适用。

Additionally, it is approved for the treatment of postoperative inflammation following ocular surgery, providing clinicians with a reliable anti-inflammatory option for managing surgical recovery.

此外，它还被批准用于眼部手术后的术后炎症治疗，为临床医生提供了一种可靠的抗炎选择，以管理手术恢复。

FDA Approval for Loteprednol Etabonate Ophthalmic Gel, 0.38%

FDA批准了0.38%的洛替泼尼松乙酸酯眼用凝胶

In a related development, Lupin also announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s Abbreviated New Drug Application (ANDA) for loteprednol etabonate ophthalmic gel, 0.38%.

与此相关的发展是，Lupin还宣布美国食品药品监督管理局（FDA）已批准该公司关于0.38%浓度的依碳酸氯倍他索眼用凝胶的简略新药申请（ANDA）。

This gel formulation, bioequivalent to Bausch & Lomb’s Lotemax SM Ophthalmic Gel, is specifically indicated for the treatment of postoperative inflammation and pain following ocular surgery.

这种凝胶配方与博士伦公司的Lotemax SM眼科凝胶生物等效，专门用于治疗眼部手术后的术后炎症和疼痛。