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Alembic Pharma gets USFDA’s nod for Bimatoprost Ophthalmic Solution

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lumigan, 0.03% of Allergan Sales, LLC (Allergan). Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Bimatoprost Ophthalmic Solution, 0.03% have an estimated market size of $76 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 90 ANDA approvals (78 final approvals and 12 tentative approvals) from USFDA. Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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