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Last Updated : Dec 10, 2018 11:43 AM IST | Source: PTI

Alembic Pharmaceuticals gets USFDA nod for 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 percent, Alembic Pharmaceuticals said in a filing to BSE.

 
 
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Drug firm Alembic Pharmaceuticals 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 percent, Alembic Pharmaceuticals said in a filing to BSE.

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

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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.

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

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First Published on Dec 10, 2018 11:36 am
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