DETROIT — Caraco Pharmaceutical Laboratories Ltd. has begun shipping azelastine ophthalmic solution 0.05%.
The company said Tuesday that the product was recently approved by the Food and Drug Administration for Sun Pharma’s abbreviated new drug application.
Azelastine ophthalmic solution is indicated for the treatment of the itching of the eyes associated with allergic conjunctivitis.
Detroit-based Caraco said the sterile azelastine hydrochloride ophthalmic solution is therapeutically equivalent to Optivar Ophthalmic Solution 0.05% from Medpoint Pharmaceuticals.
Optivar has annual sales of approximately $50 million in the United States, Caraco reported.
