Lupin gets approval from USFDA for Efinaconazole Topical Solution

03 Mar 2022 Evaluate

Lupin 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 $ 274 million in the U.S. (IQVIA MAT December 2021).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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