Cipla receives final approval for generic version of Durezol®

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• Source: Microbioz India


• Date: 12 Aug,2021

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.