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Lupin gets USFDA’s approval for Travoprost Ophthalmic Solution
May-06-2024

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Travoprost Ophthalmic Solution USP, 0.004% (RLD Travatan Z), had estimated annual sales of $77 million in the U.S. (IQVIA MAT March 2024).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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