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Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Olopatadine hydrochloride ophthalmic solution.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product, Patanol ophthalmic solution, of Alcon Laboratories Inc, the Hyderabad-based Aurobindo said in a release issued here on Tuesday.
The drug, which is ready for the launch, is used in the treatment of signs and symptoms of seasonal allergic conjunctivitis. The product has an estimated market size of $235 million for the 12 months ended October 2015, according to IMS.
Aurobindo’s scrip gained one per cent on the Bombay Stock Exchange on Tuesday and was trading at Rs 845.25 by the noon.
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