Cipla gets FDA approval for generic version of Novartis’ Durezo
Cipla Limited said that it has secured final approval for its abbreviated new drug application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05% from the US Food and Drug Administration (FDA).
Difluprednate Ophthalmic Emulsion 0.05% is a generic therapeutic equivalent version of Novartis Pharmaceutical’s Durezo.
The drug is indicated in the US for the treatment of inflammation and pain resulting from ocular surgery, and treatment of endogenous anterior uveitis.
As per IQVIA (IMS Health), Durezol had sales of nearly $106 million in the US for the 12-month period ending June 2021.
Cipla said that Difluprednate Ophthalmic Emulsion 0.05% will be available for shipping shortly.