Gland Pharma bags USFDA nod for glaucoma drug
Hyderabad: Gland Pharma Limited, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the company 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. Open-angle glaucoma is the most common type of glaucoma, a group of eye conditions that damage the optic nerve, often due to elevated intraocular pressure (IOP).
Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.
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