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

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.