Lupin receives USFDA approval for Efinaconazole Topical Solution

3 Mar 2022 , 04:05 PM

Global pharma major Lupin Limited (Lupin) on Thursday has 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, said pharma major.

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

Lupin ended at Rs720.10 apiece down by Rs8.15 or 1.12% from its previous closing of Rs728.25 apiece on the BSE.