- Lupin Limited today announced that it has received approval from the US 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).