Lupin gets USFDA nod for generic equivalent of Jublia Topical Solution
Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Mumbai, Baltimore: Drugmaker, Lupin Limited, has recently announced that the company has received tentative approval for its Efinaconazole Topical Solution, 10%, from the United States Food and Drug Administration.
The product is 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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The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle-East regions.
