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Aurobindo Pharma receives US FDA approval for allergic conjunctivitis solution

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The approved product has an estimated market size of $235 million

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market olopatadine hydrochloride ophthalmic solution USP, 0.1 per cent. 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 per cent, of Alcon Laboratories.

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 $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 used for manufacturing general injectable products. Aurobindo now has a total of 225 ANDA approvals (197 Final approvals including 10 from Aurolife Pharma and 28 tentative approvals) from US FDA.

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