Gland Pharma gets USFDA’s nod for Latanoprost Ophthalmic Solution

03 Dec 2024 Evaluate

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill). The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan, latanoprost ophthalmic solution 0.005% (50 μg/mL) held by UPJOHN US 2 LLC.

This Product is used for the treatment of high eye pressure/intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The Company expects to launch this Product through its marketing partners in FY25. According to IQVIA, the product had US sales of approximately $111.6 million for the twelve months ending December 2023. 

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.

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1801.30 -12.45 (-0.69%)
04-Dec-2024 14:51 View Price Chart
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