Lupin has received approval from the United States Food and Drug Administration (USFDA) 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. The product will be manufactured at Lupin’s Pithampur facility in India.
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in Adults with primary hyperlipidemia; and Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin Tablets (RLD Livalo) had estimated annual sales of $298 million in the U.S. (IQVIA MAT September 2023).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
