Caplin Point Laboratories’ arm gets USFDA’s approval for Difluprednate Ophthalmic Emulsion

16 Dec 2024 Evaluate

Caplin Point Laboratories’ subsidiary -- Caplin Steriles 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.

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

Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.


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