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.
