FDA Approves Generic Version of Durezol

Cipla announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05%, an AB-rated generic equivalent of Durezol^®.

Difluprednate Ophthalmic Emulsion 0.05% is a topical corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of endogenous anterior uveitis.

The Company expects to have Difluprednate Ophthalmic Emulsion 0.05% available for shipping shortly.

Reference

Cipla receives final approval for generic version of Novartis Pharmaceuticals Corporation Durezol^® (Difluprednate Ophthalmic Emulsion 0.05%). News release. Cipla. Accessed August 12, 2021. https://www.prnewswire.com/news-releases/cipla-receives-final-approval-for-generic-version-of-novartis-pharmaceuticals-corporation-durezol-difluprednate-ophthalmic-emulsion-0-05-301354144.html.