Last Updated on December 31, 2023 by The Health Master
Drug major Lupin Limited (Lupin) has received approval from the United States Food and Drug Administration (USFDA) 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 US$ 274 million in the US (IQVIA MAT December 2021).
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