USFDA approves Caplin Steriles eye drop
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-12-16 09:00 GMT | Update On 2024-12-16 09:23 GMT
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Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by the United States Food and Drug Administration (USFDA)) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05% (Eye drops).
The product is 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.
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