Caplin Point Labs Gets USFDA Nod for Generic Eyedrop - Difluprednate

New Delhi, Dec 16 (PTI) 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 (USFDA) is for the abbreviated new drug application (ANDA) of Difluprednate Ophthalmic emulsion, 0.05 per cent, Caplin Point Laboratories said in a regulatory filing.

It is a generic therapeutic equivalent version of the Reference Listed Drug (RLD) 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 per cent (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 per cent, had US sales of approximately USD 21 million for the 12-month period ending October 2024.