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Gland Pharma Ltd has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Vyzulta Ophthalmic Solution registered by Bausch & Lomb Inc. (Bausch & Lomb)
Based on the available updates, the Hyderabad-based Gland Pharma 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 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 $153 million for the 12 months ended December 2023, according to a release.
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