10Jul 2024
Alembic Pharmaceuticals Receives FDA Approval for Bromfenac Ophthalmic Solution

Alembic Pharmaceuticals Receives FDA Approval for Bromfenac Ophthalmic Solution

Alembic Pharmaceuticals Limited has secured final approval from the US FDA for Bromfenac Ophthalmic Solution, 0.07%. This nonsteroidal anti-inflammatory drug (NSAID) is indicated for managing postoperative inflammation and reducing ocular pain following cataract surgery. The approved ANDA is deemed therapeutically equivalent to Bausch & Lomb's Prolensa Ophthalmic Solution, 0.07%. With an estimated market size of $168 million for the twelve months ending March 2024 (as per IQVIA), Alembic's new approval marks a significant milestone in expanding its portfolio of ophthalmic solutions in the US market.

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