Alembic Pharma bags USFDA nod for Bromfenac Ophthalmic Solution
Vadodara: Alembic Pharmaceuticals Limited has announced that the Company 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.
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.
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.
Medical Dialogues team had earlier reported that the Company had received 11 product approvals both final and tentative from the USFDA during the quarter ended 30th June, 2024.
Read also: Alembic Pharma receives 11 USFDA product approvals (final & tentative) during quarter ended 30 June
Headquartered in India, Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Its state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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