Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

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 Bromfenac Ophthalmic Solution, 0.07%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb Incorporated (Bausch). Bromfenac Ophthalmic Solution 0.07% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Refer label for a detailed indication.

Bromfenac Ophthalmic Solution, 0.07% has an estimated market size of US$ 168 million for twelve months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 207 ANDA approvals (180 final approvals and 27 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 984.95 as compared to the previous close of Rs. 985.05. The total number of shares traded during the day was 12512 in over 1267 trades.

The stock hit an intraday high of Rs. 1005.95 and intraday low of 975.60. The net turnover during the day was Rs. 12399510.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA BromfenacOphthalmicSolution