Alembic Pharma gets USFDA nod for Dorzolamide Hydrochloride Ophthalmic Solution

The approved Dorzolamide Hydrochloride Ophthalmic Solution is therapeutically equivalent to the reference listed drug Trusopt Ophthalmic Solution, of Merck Sharp & Dohme Corp.

New Delhi: Drug firm Alembic Pharmaceuticals on August 13 said it has received approval from the US health regulator for Dorzolamide Hydrochloride Ophthalmic Solution. The drug is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

The approved product is therapeutically equivalent to the reference listed drug Trusopt Ophthalmic Solution, of Merck Sharp & Dohme Corp.

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

Quoting IQVIA data, Alembic Pharmaceuticals said Dorzolamide Hydrochloride Ophthalmic Solution USP, 2 percent, has an estimated market size of USD 35 million for twelve months ending December 2018.

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