Aurobindo Pharma Limited announced today that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Olopatadine hydrochloride opthalmic solution.
Olopatadine Hydrochloride is used in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. The approved product has an estimated market size of $235 million for the twelve months ending October 2015, according to the company’s statement.
The approved Approved New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Patanol of Alcon Laboratories, Inc. The product is ready for the launch, according to the company.
