Cipla announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the United States Food and Drug Administration (US FDA).

Cipla’s Difluprednate Ophthalmic Emulsion 0.05% is an AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation’s Durezol. It is used for the treatment of inflammation and pain associated with ocular surgery and the treatment of endogenous anterior uveitis.

According to IQVIA (IMS Health), Durezol had US sales of approximately US $ 106mn for the 12 months ending June 2021.