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Last Updated : Aug 13, 2019 10:50 AM IST | Source: PTI

Alembic Pharma gets USFDA nod for ophthalmic solution

The drug is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

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 percent, Alembic Pharmaceuticals said in a BSE filing.

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

The company currently has a total of 101 ANDA approvals (89 final approvals and 12 tentative approvals) from the USFDA, it added.

Shares of Alembic Pharmaceuticals were trading 2.17 percent lower at Rs 533.50 apiece on the BSE.

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First Published on Aug 13, 2019 10:42 am
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