Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution

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 BSE.

New Delhi: Drug firm Alembic Pharmaceuticals Monday said it 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 BSE.

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The approved product is therapeutically equivalent to the reference listed drug product (RLD) Patanol ophthalmic solution, 0.1 per cent, of Novartis Pharmaceuticals Corporation, the company added.

Quoting IQVIA data, Alembic Pharma said Olopatadine Hydrochloride ophthalmic solution has an estimated market size of USD 61 million for 12 months ending December 2017.

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The company said it currently has 83 ANDA approvals from USFDA.

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