Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill).
Latanoprost is commonly used to treat elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension.
This approval allows the company to manufacture and market the generic version of the product in the United States.
The product is a cost-effective alternative to branded versions and aligns with Gland Pharma’s focus on generic injectables and solutions, enhancing its presence in the U.S. pharmaceutical market.
Gland Pharma stated that ,”its Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill) is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan (latanoprost ophthalmic solution 0.005% or 50 µg/mL), manufactured by UPJOHN US 2 LLC.“
The company plans to launch this product in 2025 in collaboration with its marketing partners.
According to IQVIA, the product generated approximately USD 111.6 million in U.S. sales over the twelve months ending in December 2023, the company reported.
JYOTI