Mumbai : Cipla Limited on Thursday 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 AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation’s Durezol®.
It is used in treatment of inflammation and pain associated with ocular surgery. It is also used in treatment of endogenous anterior uveitis. According to IQVIA (IMS Health), Durezol® had US sales of approximately $106mn for the 12-month period ending June 2021.