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

 Efinaconazole Topical Solution, 10% (RLD: Jublia Topical Solution, 10%) had estimated annual sales of USD 274 million in the U.S. (IQVIA MAT December 2021).