Lupin gets tentative approval from USFDA for Efinaconazole Topical Solution

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

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 $222.9 million in the US (IQVIA MAT September 2020).