Alembic Pharmaceuticals Limited announces USFDA Final Approval for Difluprednate Ophthalmic Emulsion

Alembic Pharmaceuticals Limited announces USFDA Final Approval for Difluprednate Ophthalmic Emulsion

 Alembic Pharmaceuticals Limited (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. Refer label for a detailed indication.

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