Lupin Receives US FDA Approval for Travoprost Ophthalmic Solution USP

Lupin Receives US FDA Approval for Travoprost Ophthalmic Solution USP

By, Admin 7 May 2024

Overview

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for travoprost ophthalmic solution USP, 0.004% (ionic buffered solution), to market a generic equivalent to the reference listed drug (RLD) Travatan Z ophthalmic solution, 0.004%, of Sandoz Inc. The product will be manufactured at Lupin’s Pithampur facility in India. 

Travoprost Ophthalmic Solution: Indications

Travoprost ophthalmic solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. 

Annual sales

Travoprost ophthalmic solution USP, 0.004% (RLD Travatan Z), had estimated annual sales of USD 77 million in the US (IQVIA MAT March 2024). 

Lupin

  • Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 
  • The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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