Sun Pharmaceutical announced today that the United States' Food and Drug Administration (US FDA) Department has approved for an Abbreviated New Drug Application (ANDA) to market a generic version of Optivar, the azelastine ophthalmic solution, 0.05 per cent.
Azelastine is a selective antihistamine used for the treatment of itching of eyes associated with conjunctivitis.
The sterile azelastine hydrochloride ophthalmic solution is therapeutically equivalent to Optivar ophthalmic solution, 0.05 per cent from Medpointe pharmaceuticals, which has an annual sale of approximately $50 million in United States.