Alembic’s Bimatoprost gets USFDA approval

Alembic Pharmaceuticals Limited recently announced that the company 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 US$ 10 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.