Gland Pharma Limited on Tuesday said that it has received approval from the United States Food and Drug Administration (USFDA) for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill).
According to the company’s statement, the Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan, latanoprost ophthalmic solution 0.005% (50 pg/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 USD 111.6 million for the twelve months ending December 2023, it stated.
