Lupin receives USFDA approval for Travoprost Ophthalmic Solution USP

Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. 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 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 USD 77 million in the U.S. (IQVIA MAT March 2024).

 

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