Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
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.
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