Lupin Limited announced that it has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Loteprednol Etabonate Ophthalmic Gel, 0.38%, a bioequivalent to Lotemax SM Ophthalmic Gel of Bausch & Lomb, the company said in a press release. 

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery.

According to the company, 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.