Lupin Bags USFDA Nod For Cholesterol Lowering Drug Pitavastatin

Lupin Limited has announced that the United States Food and Drug Administration (US FDA) has approved its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to market a generic equivalent of Kowa Company Limited's Livalo Tablets, 1 mg, 2 mg, and 4 mg.

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), as per medicaldialogues. 

Lupin's Pithampur factory in India will manufacture the product. Pitavastatin Tablets (RLD Livalo) has expected annual sales in the United States of USD 298 million (IQVIA MAT September 2023).

Lupin is a worldwide pharmaceutical firm based in Mumbai, India that focuses on innovation. The Company develops and commercializes a diverse variety of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. The company focuses in the cardiovascular, anti-diabetic, and respiratory sectors, and it also has a strong presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health segments.

Lupin is the third-largest pharmaceutical firm in the United States in terms of prescriptions. In FY23, the firm spent 7.9% of its revenue on research & development. Lupin has 15 production facilities, 7 research centers, and over 20,000 employees worldwide, and has been honored as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals industry on several occasions.