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

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Lupin Limited (Lupin) announced that the United States Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA), Efinaconazole Topical Solution, 10%, to bring a generic counterpart of Bausch Health Americas, Inc.’s Jublia Topical Solution, 10%, to market. Lupin’s factory in Pithampur, India, will produce the product.

In the United States, Efinaconazole Topical Solution, 10% (RLD: Jublia Topical Solution, 10%) had an expected annual sales of USD 274 million.

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