Lupin Limited Receives FDA Approval for Travoprost Ophthalmic Solution USP

Lupin Limited, a global pharma major, announced the receipt of approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%. This approval allows Lupin 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 USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. The estimated annual sales of the RLD in the US were USD 77 million (IQVIA MAT March 2024).