Alembic Pharmaceuticals Receives USFDA Approval for Travoprost Ophthalmic Solution

Alembic Pharmaceuticals Limited has 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% (lonic Buffered Solution). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. 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 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.