Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for olopatadine hydrochloride ophthalmic solution USP, 0.7 per cent (OTC).

The approved product is therapeutically equivalent to Pataday Once Daily Relief, 0.7 percent, marketed by Alcon Laboratories. It is indicated for the temporary relief of itchy eyes caused by pollen, ragweed, grass, animal hair and dander.

According to IQVIA, the US market for olopatadine hydrochloride ophthalmic solution USP, 0.7 per cent, was estimated at USD 20 million for the 12 months ended September 2026.

The ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies.

With this approval, Alembic Pharmaceuticals has secured a cumulative total of 248 ANDA approvals from the US FDA, comprising 229 final approvals and 19 tentative approvals.