Cipla receives US FDA approval for inflammation drug

The drug is the generic version of Novartis Pharmaceuticals Corporation Durezol

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05 per cent from the United States Food and Drug Administration (US FDA). 

Cipla’s Difluprednate Ophthalmic Emulsion 0.05 per cent is AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation’s Durezol. The drug is used to treat inflammation and pain associated with ocular surgery and endogenous anterior uveitis. 

According to IQVIA (IMS Health), Durezol had US sales of approximately $106 million for the 12 months ending June 2021. The product will be available for shipping soon.