Cipla gets USFDA nod for its abbreviated New Drug Application

Drug firm Cipla Limited on Thursday, August 12, 2021, announced that it has received final approval from the US health regulator for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05%.

CIPLA in a regulatory filing said that it has received approval from the United States Food and Drug Administration (US FDA) to market its product which is a generic version of Novartis Pharmaceuticals Corporation Durezol® (Difluprednate Ophthalmic Emulsion 0.05%).

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 months ending June 2021. The product will be available for shipping soon.

Shares of Cipla were trading 0.44 per cent down at Rs 905.85 apiece at 2:58 pm on the NSE.