Alembic Pharmaceuticals Limited (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 elevatedintraocular 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.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.1006.8 as compared to the previous close of Rs. 983. The total number of shares traded during the day was 65545 in over 3412 trades.
The stock hit an intraday high of Rs. 1034 and intraday low of 982.1. The net turnover during the day was Rs. 65915558.