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Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

30-Apr-2025, 02:20

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution, 0.024%.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc.

This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.