Alembic Pharmaceuticals Limited 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%, an over-the-counter eye drop. According to a company press release, the approved ANDA is therapeutically equivalent to the reference listed drug, Pataday Once Daily Relief 0.7% (Alcon).
The ophthalmic solution is indicated for the temporary relief of itchy eyes caused by pollen, ragweed, grass, animal hair, and dander.
The ANDA was developed in collaboration with Orbicular Pharmaceutical Technologies Pvt Ltd., the company said.







