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Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

30-Apr-25 14:20 Hrs IST

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.

24,334.20 -1.75 (-0.01%)

80,242.24 -46.14 ( -0.06%)

55,087.15 -304.10 ( -0.55%)

35,794.95 -125.45 ( -0.35%)

40,538.66 290.07 (0.72%)

5,579.50 29.75 (0.54%)

36,006.39 166.40 (0.46%)

8,463.46 46.12 (0.55%)

85.20 -0.17 (-0.20%)

96.93 -0.07 (-0.07%)

113.83 0.22 (0.19%)

0.60 0.00 (0.27%)