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NEW DELHI: Drug company Lupin on Thursday said it has received tentative nod in the US health regulator to market generic Efinaconazole topical solution used for treatment of fungal infections of toenails.
The business has received tentative approval to market its Efinaconazole topical solution, 10%, by the United States Food and Drug Administration (USFDA), Lupin said in a regulatory filing.
The product is a generic version of Bausch Health Americas, Inc’s Jublia topical solution in the same power, it added.
According to IQVIA MAT September 2020 data, Efinaconazole topical solution, 10 percent had estimated annual sales of USD 222.9 million (about Rs 1,640 crore) in the US, the filing stated.
Shares of Lupin Ltd on Thursday closed 1.37Â percent higher at Rs 976.15 per scrip on the BSE.