Gland Pharma receives Tentative Approval from the USFDA for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma Limited (Gland or Company), a generic injectable-focused pharmaceutical company, 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 approximately USD 153 million for the twelve months ended December 2023.

Shares of Gland Pharma Limited was last trading in BSE at Rs. 1978.30 as compared to the previous close of Rs. 1993.90. The total number of shares traded during the day was 108307 in over 1474 trades.

The stock hit an intraday high of Rs. 2028.25 and intraday low of 1935.30. The net turnover during the day was Rs. 217363192.00.

Source : Equity Bulls

Keywords

GlandPharma INE068V01023 USFDA TentativeApproval LatanoprosteneBunod OphthalmicSolution