Alembic Pharmaceuticals Limited announces USFDA Final Approval for Travoprost Ophthalmic Solution USP, 0.004percent (Ionic Buffered Solution)
Mumbai, Dec 18: Alembic Pharmaceuticals Limited (Alembic) today 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. Refer label for a detailed indication.
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.