Lupin Receives Approval from U.S. FDA for Efinaconazole Topical Solution

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).

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