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Alembic Pharmaceuticals (Alembic) today announced that it has received
final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cosopt Ophthalmic Solution, 2% and 0.5%, of Akorn Operating Company LLC.
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is a combination of dorzolamide hydrochloride carbonic anhydrase inhibitor, and timolol maleate, a beta-adrenergic receptor blocking agent, indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
Dorzolamide Hydrochloride and Tirnolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US$ 80 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from USFDA.
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