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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