Gland Pharma Receives US FDA Tentative Approval for Latanoprostene Bunod Ophthalmic Solution

Gland Pharma Receives US FDA Tentative Approval for Latanoprostene Bunod Ophthalmic Solution

By, Admin 24 July 2024

Overview

Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (FDA) 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)

1st ANDA Applicant 

  • 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

  • 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

  • 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 one of the largest injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

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