Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (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 Pharmaceuticals 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.