Alembic Pharmaceuticals receives USFDA approval for ANDA Bimatoprost Ophthalmic Solution
Capital Market 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 US$ 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.
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