Gland Pharma bags USFDA nod for glaucoma drug
Hyderabad: Gland Pharma Limited, a generic injectable & ophthalmic focused pharmaceutical company, has announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Latanoprostene Bunod Ophthalmic Solution,0.024%.
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, of Bausch and Lomb, Inc.
This Product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Open-angle glaucoma is the most common type of glaucoma, a group of eye conditions that damage the optic nerve, often due to elevated intraocular pressure (IOP).
Gland Pharma is the exclusive First-to-File and is eligible for 180 days of generic drug exclusivity.
According to IQVIA, the product had US sales of approximately USD 171 million for the twelve months ending February.
Medical Dialogues team had earlier reported that Gland Pharma had received approval from the USFDA for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill) for high eye pressure/intraocular pressure (IOP) in patients with openangle glaucoma or ocular hypertension.
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Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become a injectable-focused company with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and market sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
