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, 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 $222.9 million in the U.S. (IQVIA MAT September 2020).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.