Alembic Pharmaceuticals Receives USFDA Final Approval for Difluprednate Ophthalmic Emulsion, 0.05%

Alembic Pharmaceuticals Limited has 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. 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. Alembic has a cumulative total of 233 ANDA approvals (213 final approvals and 20 tentative approvals) from USFDA.