Lupin gets USFDA approval to market Efinaconazole Topical Solution in the US

Drug major Lupin Limited on Thursday said that it has received approval from the US health regulator to market Efinaconazole Topical Solution in the American market. The product will be manufactured at Lupin's facility in Pithampur, India.

The pharma major in a regulatory filing at BSE said that it 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.

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).

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions.