Lupin bags tentative USFDA nod for Loteprednol Etabonate Ophthalmic Gel
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative 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%, to market a generic equivalent of Lotemax SM Ophthalmic Gel of Bausch & Lomb Inc.
Lupin is the exclusive first-to-file for this product and may be eligible to receive a 180-day exclusivity. This product would be manufactured at Lupin’s Pithampur facility in India.
Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of USD 36 million in the U.S. (IQVIA MAT November 2024).
Medical Dialogues team had earlier reported that the company had received approval from the U.S. FDA for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.1%. Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
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, along with a workforce of over 22,000 professionals.
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