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Alembic Pharmaceuticals receives USFDA approval for Durezol Ophthalmic Emulsion, 0.05%
Jan 27,2026
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Durezol Ophthalmic Emulsion, 0.05%, of Sandoz Inc. (Sandoz). Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery and also indicated for the treatment of endogenous anterior uveitis.