Cipla bags USFDA nod for generic version of Durezol
Mumbai: Drug major, Cipla Limited, today announced that the company 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 (USFDA).
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.
The product will be available for shipping soon, the company said.
According to IQVIA (IMS Health), Durezol had US sales of approximately $106mn for the 12-month period ending June 2021.
Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai.
Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions.