By: IPP Bureau
Last updated : March 03, 2022 5:41 pm
The product will be manufactured at Lupin’s facility in Pithampur, India
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).