Alembic Pharma receives USFDA Approval for Bromfenac Ophthalmic Solution 0.09%

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Biznextindia : Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bromfenac Ophthalmic Solution 0.09%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09%, of Bausch & Lomb Incorporated (Bausch & Lomb). Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac Ophthalmic Solution 0.09% has an estimated market size of US$ 6 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 96 ANDA approvals (84 final approvals and 12 tentative approvals) from USFDA.

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