The U.S. FDA approval came for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution. File.
| Photo Credit: Reuters
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.
Published – December 19, 2025 09:55 am IST
