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Alembic Pharma gets US FDA nod for elevated intraocular pressure drug

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

Drug firm Alembic Pharmaceuticals has received final nod from the US health regulator for its Timolol Maleate ophthalmic gel forming solution used for the treatment of elevated intraocular pressure.

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The company has received final approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Timolol Maleate ophthalmic gel forming solution, 0.25 per cent and 0.5 per cent, Alembic Pharma said in a filing to BSE.

The product is generic version of Bausch Health US’ Timoptic-XE ophthalmic gel forming solution in the same strengths, it added.

The company “has been granted a competitive generic therapies (CGT) designation for this ANDA and it is eligible for 180 days of CGT exclusivity as it is the first approved ANDA,” Alembic Pharma said.

This application has been co-developed in partnership with Orbicular Pharmaceutical Technologies, it added.

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

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