Cipla receives final approval for generic version of Novartis Pharmaceuticals Corporation Durezol® (Difluprednate Ophthalmic Emulsion 0.05%)
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.