Cipla yesterday said it has received approval from the US health regulator to market Difluprednate Ophthalmic Emulsion, used in the treatment of inflammation and pain associated with ocular surgery, in the American market.
The company has received final approval from the US Food and Drug Administration (FDA) to market its product which is a generic version of Novartis Pharmaceutical Corporation’s Durezol, Cipla said in a statement.
The product is also used for the treatment of endogenous anterior uveitis.
According to IQVIA (IMS Health), Durezol had US sales of around $106 million for the 12-month period ending June 2021.
The product will be available for shipping soon, the Mumbai-based drug major said.