Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. (Sandoz).

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 

Travoprost Ophthalmic Solution USP, 0.004%, has an estimated market size of US$ 61 million for twelve months ending September 2025 according to IQVIA.

Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.