Alembic Pharmaceuticals announces USFDA Final Approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%

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) Brimonidine Tartrate Ophthalmic Solution, 0.15%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Alphagan P Ophthalmic Solution, 0.15%, of AbbVie Inc. Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Brimonidine Tartrate Ophthalmic Solution, 0.15% has an estimated market size of US$ 97 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 180 ANDA approvals (156 final approvals and 24 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 468.30 as compared to the previous close of Rs. 478.20. The total number of shares traded during the day was 32088 in over 1626 trades.

The stock hit an intraday high of Rs. 484.65 and intraday low of 463.30. The net turnover during the day was Rs. 15139858.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA BrimonidineTartrate OphthalmicSolution