Lupin receives USFDA tentative approval for Efinaconazole Topical Solution

Lupin has received tentative approval for its Efinaconazole Topical Solution, 10%, from the United States Food and Drug Administration, to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.

Efinaconazole Topical Solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Efinaconazole Topical Solution, 10%, (RLD: Jublia) had estimated annual sales of USD 222.9 million in the U.S. (IQVIA MAT September 2020).

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