Alembic Pharma gets tentative USFDA nod for Bimatoprost Ophthalmic Solution

Alembic Pharma's Bimatoprost Ophthalmic Solution is therapeutically equivalent to the reference listed drug product Lumigan ophthalmic solution 0.01 per cent, of Allergan Inc.

New Delhi: Drug firm Alembic Pharmaceuticals on Friday said it has received tentative approval from the US health regulator for Bimatoprost Ophthalmic Solution, indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The approved product is therapeutically equivalent to the reference listed drug product Lumigan ophthalmic solution 0.01 per cent, of Allergan Inc.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bimatoprost Ophthalmic Solution 0.01 per cent, Alembic Pharmaceuticals said in a BSE filing.

Quoting IQVIA sales data, the company said, Bimatoprost Ophthalmic Solution has an estimated market size of USD 704 million for 12 months, ending December 2018.

The company said it now has a total of 100 ANDA approvals from the USFDA.

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