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Alembic Pharma gets USFDA’s final approval for Travoprost Ophthalmic Solution

24 Dec 2019 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Travatan Ophthalmic Solution, 0.004%, of Alcon Pharmaceuticals Limited (Alcon). Travoprost Ophthalmic Solution USP, 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Alembic has a cumulative total of 110 ANDA approvals (97 final approvals and 13 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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