Cipla receives final approval for its abbreviated new drug application

Cipla’s Difluprednate Ophthalmic Emulsion 0.05 per cent is an AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation’s Durezol®. 

Pharmaceutical major Cipla has received final approval for generic version of Novartis Pharmaceuticals Corporation Durezol® (Difluprednate Ophthalmic Emulsion 0.05 per cent) from United States Food & Drug Administration (US DA). 

Cipla’s Difluprednate Ophthalmic Emulsion 0.05 per cent is an AB-rated generic therapeutic equivalent version of Novartis Pharmaceutical Corporation’s Durezol®.  It is used for the treatment of inflammation and pain associated with ocular surgery as well as the treatment of endogenous anterior uveitis. 

According to IQVIA (IMS Health), Durezol® had US sales of approximately $106 million for the 12-month period ending June 2021. The company said that this product will be available for shipping soon. 

Cipla is a global pharmaceutical company focussed on agile & sustainable growth, complex generics as well as the deepening portfolio in home markets of India, South Africa, North America along with key regulated and emerging markets. The company has 46 manufacturing sites around the world that produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets. 

The shares of Cipla are currently trading flat but touched an intraday high of Rs 915.45 on August 12, 2021.