Caplin Steriles Receives FDA Approval For Generic Difluprednate Eye Drops

Caplin Point Laboratories Ltd. on Monday said its arm Caplin Steriles Ltd. has received approval from the US health regulator for its generic version of Difluprednate eye drop indicated in the treatment of inflammation and pain associated with ocular surgery. The approval granted by the US Food and Drug Administration is for the abbreviated new drug application of Difluprednate Ophthalmic emulsion, 0.05%, Caplin Point Laboratories said in a regulatory filing.

It is a generic therapeutic equivalent version of the Reference Listed Drug DUREZOL, from Sandoz Inc, the company said.

"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," Caplin Chairman CC Paarthipan said.

Difluprednate ophthalmic emulsion, 0.05% (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 inflammation inside the eyes.

Citing IQVIA data, the company said Difluprednate ophthalmic emulsion, 0.5%, had US sales of approximately $21 million for the 12-month period ending October 2024.