Alembic Pharma gets USFDA nod for ophthalmic solution

Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye.

The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 per cent and 0.5 per cent, of Akorn Operating Company LLC.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent, Alembic Pharmaceuticals said in a regulatory filing.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. Quoting IQVIA data, Alembic Pharma said Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent has an estimated market size of USD 80 million for twelve months ending December 2020.

Alembic now has a total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from USFDA.

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