FDA approves India’s Aurobindo’s generic version of Alcon’s Patanol

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% which makes the product is ready for launch.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Patanol Ophthalmic Solution/Drops, 0.1%, of Alcon Laboratories, Inc.

Olopatadine Hydrochloride Ophthalmic Solution is used in the treatment of the signs and symptoms of seasonal allergic conjunctivitis. The approved product has an estimated market size of US$235 million for the twelve months ending October 2015 according to IMS.

This is the 20th ANDA (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 225 ANDA approvals (197 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.