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Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication to treat conditions related to high pressure in the eye.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Latanoprostene Bunod Ophthalmic Solution, (0.024 per cent), the drug firm said in a statement.
The company's product is bioequivalent and therapeutically equivalent to Bausch and Lomb, Inc's Vyzulta ophthalmic solution, it added.
The product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The company is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity, Gland Pharma said.
According to IQVIA, the product had sales of around USD 171 million in the US for the 12 months ending February 2025.
Shares of Gland Pharma on Wednesday ended 1.04 per cent down at Rs 1,398.35 apiece on the BSE.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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