Alembic Pharmaceuticals has secured US Food & Drug Administration (USFDA) final approval for its Difluprednate Ophthalmic Emulsion, 0.05%. This approval allows Alembic to market a therapeutically equivalent version of Durezol Ophthalmic Emulsion, used for treating inflammation and pain related to ocular surgery, as well as endogenous anterior uveitis. This adds to Alembic’s total of 233 ANDA approvals.
USFDA Approval for Ophthalmic Treatment
Alembic Pharmaceuticals Limited has announced it received final approval from the US Food & Drug Administration (USFDA) for Difluprednate Ophthalmic Emulsion, 0.05%. This was announced on January 27, 2026.
Equivalent to Reference Product
The approved Abbreviated New Drug Application (ANDA) is considered therapeutically equivalent to the reference listed drug product (RLD), Durezol Ophthalmic Emulsion, 0.05%, marketed by Sandoz Inc. The medication is indicated for treating inflammation and pain following ocular surgery, and for treating endogenous anterior uveitis. Patients should refer to the product label for comprehensive details.
ANDA Approvals Update
With this recent approval, Alembic Pharmaceuticals now holds a cumulative total of 233 ANDA approvals. This includes 213 final approvals and 20 tentative approvals from the USFDA, solidifying its position in the pharmaceutical market.
Source: BSE
