Gland Pharma bags tentative USFDA nod for Latanoprostene Bunod Ophthalmic Solution
Hyderabad: Generic injectable-focused pharmaceutical company, Gland Pharma Limited, has received tentative approval from the United States Food and Drug Administration (USFDA) 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%, registered by Bausch & Lomb Inc.
"Based on the available updates, the Company believes that it is the first applicant to have filed its ANDA with Paragraph IV certification," Gland Pharma said in a BSE filing.
Upon final approval, the Company may be eligible for 180 days of generic drug exclusivity.
Latanoprostene Bunod Ophthalmic Solution, 0.024%, is indicated for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
According to IQVIA, the product had US sales of approximately USD 153 million for the twelve months ended December 2023.
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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 growing injectable-focused companies, 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 markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
Read also: Gland Pharma names Srinivas Sadu as Executive Chairman, CEO
