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Alembic Pharmaceuticals has received approval from the US health regulator for Olopatadine Hydrochloride ophthalmic solution, used to treat allergic conjunctivitis.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine Hydrochloride ophthalmic solution USP, 0.1 per cent, Alembic Pharmaceuticals said in a filing to the BSE today.
The approved product is therapeutically equivalent to the reference listed drug product Patanol ophthalmic solution, 0.1 per cent, of Novartis Pharmaceuticals Corporation.
Quoting IQVIA data, Alembic Pharma said Olopatadine Hydrochloride ophthalmic solution has an estimated market size of $61 million for the 12 months ended December 2017. Currently, it has 83 ANDA approvals from USFDA.
Shares of Alembic Pharmaceuticals were trading 0.07 per cent lower at Rs 614 apiece on the BSE.
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