FDA Approves Cipla’s ANDA Application for Generic of Novartis’s Durezol

Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.

Cipla—a global pharmaceutical company that specializes in complex generics—announced in an August 12, 2021 press release that it received final approval for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05% from FDA. Difluprednate ophthalmic emulsion 0.05% is the generic version of Novartis’s Durezol and is used for the treatment of inflammation and pain associated with ocular surgery as well as for the treatment of endogenous anterior uveitis.

Novartis’s Durezol had US sales of approximately $106 million for the 12-month period (ending June 2021), according to IQVIA (IMS Health). Cipla’s press release states difluprednate ophthalmic emulsion 0.05% will be available for shipping soon.

Source: Cipla