Gland Pharma gets USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

23 Jul 2024 Evaluate

Gland Pharma 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. (Bausch & Lomb). Based on the available updates, the company believes that it is the first applicant to have filed its ANDA with Paragraph IV certification. 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 around $153 million for the twelve months ended December 2023.

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.


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