Lupin gains US FDA approval for eye gel, secures exclusivity

Lupin Limited (BSE: LUPIN) announced it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Loteprednol Etabonate Ophthalmic Gel, 0.38%, a generic equivalent to Lotemax® SM Ophthalmic Gel of Bausch & Lomb Inc. As the exclusive first-to-file applicant, Lupin is eligible for 180 days of generic drug exclusivity. Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery. The drug's annual sales are estimated at USD 29 million in the U.S. Lupin will manufacture the product at its Pithampur facility in India.