Cipla Receives US FDA Approval For Generic Durezol
Cipla Limited 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 (FDA).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 treatment of inflammation and pain associated with ocular surgery and 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 product will be available for shipping soon.
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