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Mumbai, India; August 12, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today 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 for the following: • Treatment of inflammation and pain associated with ocular surgery. • 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. The product will be available for shipping soon.
