Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery

Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD) DUREZOL, from Sandoz Inc.

“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”, commented Chairman C.C.Paarthipan.

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 endogenous anterior uveitis. According to IQVIATM (IMS Health), Difluprednate Ophthalmic Emulsion, 0.5% had US sales of approximately $21 million for the 12-month period ending October 2024.