Mumbai, Dec. 16 -- The approved ANDA is a generic therapeutic equivalent version of the reference listed drug (RLD) Durezol, from Sandoz Inc.

Difluprednate Ophthalmic Emulsion (Eye drops) is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery, and in the treatment of endogenous anterior uveitis.

According to IQVIA (IMS Health), the approved drug had US sales of approximately $21 million for the 12-month period ending October 2024.

"We're pleased to receive a first cycle approval for this complex emulsion product. Few more emulsion and suspension products have been filed or in the pipeline, which should augment Caplin Steriles' portfolio in the US and emerging markets", com...