Lupin gets USFDA nod for cholesterol lowering drug Pitavastatin

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to market a generic equivalent of Livalo Tablets, 1 mg, 2 mg, and 4 mg, of Kowa Company Limited.

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:

 Adults with primary hyperlipidemia.

 Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).

The product will be manufactured at Lupin’s Pithampur facility in India.

Pitavastatin Tablets (RLD Livalo) had estimated annual sales of USD 298 million in the U.S. (IQVIA MAT September 2023). 

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

Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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