Gland Pharma bags tentative USFDA nod for Latanoprostene Bunod Ophthalmic Solution

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-07-24 06:00 GMT | Update On 2024-07-24 06:00 GMT

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Gland Pharma bags tentative USFDA nod for Latanoprostene Bunod Ophthalmic Solution

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