Alembic Pharma gets USFDA nod for Travoprost glaucoma drug

Drugmaker Alembic Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (ionic buffered solution).

The approved ANDA is therapeutically equivalent to the reference listed drug Travatan Z Ophthalmic Solution, 0.004%, of Sandoz. Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The product has an estimated market size of $61 million for twelve months ending September 2025, Alembic said citing IQVIA numbers.