Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP.
The product is therapeutically equivalent to Alcon Laboratories' reference drug, Pataday Once Daily Relief 0.7%.
The eye drops are indicated for temporary relief from itchy eyes caused by pollen, ragweed, grass, animal hair and dander, the company said in a regulatory filing.