Lupin gets tentative USFDA nod for diabetes drug Empagliflozin
Mumbai, Baltimore: Pharma major Lupin Limited has announced that it has received tentative approval for its Empagliflozin Tablets, 10 mg and 25 mg, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Jardiance® Tablets, 10 mg and 25 mg, of Boehringer Ingelheim Pharmaceuticals, Inc.
Empagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Empagliflozin Tablets, 10 mg and 25 mg (RLD: Jardiance® ) had an annual sales of approximately USD 4,368 million in the U.S. (IQVIA MAT Mar 2020).
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
The Company 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 specializes 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.