Lupin bags USFDA approval for Efinaconazole Topical Solution

The product will be manufactured at Lupin’s facility in Pithampur

Lupin has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Efinaconazole Topical Solution, 10 per cent to market a generic equivalent of Jublia Topical Solution, 10 per cent, of Bausch Health Americas, Inc. The product will be manufactured at Lupin’s facility in Pithampur.

Efinaconazole Topical Solution, 10 per cent had estimated annual sales of $274 million in the US.