Lupin receives USFDA approval for Efinaconazole Topical Solution

Lupin has received USFDA approval 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. ((QVIA MAT December 2021).

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