Lupin secures USFDA approval for Loteprednol Etabonate Ophthalmic Gel
The product is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.;
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%.
Loteprednol Etabonate Ophthalmic Gel, 0.38% is bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc.
Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity.
This product will be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.
Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of USD 29 million in the U.S. (IQVIA MAT May 2025).
The approval adds to Lupin’s growing momentum in the global eye-care segment. Medical Dialogues team had earlier reported in May that Lupin entered into a license and supply agreement with SteinCares, a specialty healthcare company in Latin America, for commercialization of Lupin’s biosimilar ranibizumab across Latin America excluding Mexico and Argentina. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Myopic Choroidal Neovascularization (mCNV).
Read also: Lupin, SteinCares team up to bring Vision drug Ranibizumab to Latin America
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
Read also: Lupin bags tentative nod from USFDA for partial-onset seizures drug Oxcarbazepine ER
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