Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

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

  • By IPP Bureau | May 01, 2025

Gland Pharma Limited, a generic injectable & ophthalmicfocused pharmaceutical 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. 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.

According to IQVIA, the product had US sales of approximately US$ 171 million for the twelve months ending February 2025.

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