Lupin gets USFDA approval for post-eye surgery drug

2 Jul 2025 , 11:27 AM

Lupin Limited announced that it has secured the United States Food and Drug Administration (USFDA)’s approval for its abbreviated new drug application (ANDA). The approval is received for loteprednol etabonate ophthalmic gel, 0.38%.

The stated product is a generic version of Lotemax SM ophthalmic gel, 0.38%. The was originally developed by Bausch & Lomb Inc. Lupin is the first-to-file exclusive for this product. This is eligible for 180 days of generic drug exclusivity. The company will manufacture the product at its facility situated in India. 

Loteprednol etabonate ophthalmic gel, 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. According to data released by IQVIA MAT in May 2025 loteprednol etabonate ophthalmic gel, 0.38% (RLD Lotemax SM) registered an estimated annual sales of $29 Million in the US.

Last week, Lupin announced it has launched prucalopride tablets in the United States after receiving final approval from the FDA.

These tablets are used in the treatment of chronic idiopathic constipation (CIC) in adults. This drug is available in 1 mg and 2 mg vials. As per the company, these are bioequivalent to Motegrity tablets of Takeda Pharmaceuticals U.S.A., Inc.

The stated drug shall be manufactured at its facility situated in Goa.

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