Express Pharma

Lupin gets tentative approval from USFDA for Efinaconazole Topical Solution

It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes

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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).

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