Cipla receives final approval for Difluprednate Ophthalmic Emulsion

Cipla announced that it 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 (US 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 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-month period ending June 2021.

The product will be available for shipping soon.

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