Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg have received final approval from the United States Food and Drug Administration (USFDA) (USRLD: Livalo Tablets). Pitavastatin is an HMG-CoA reductase inhibitor that is used as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to lower total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and increase high-density lipoprotein cholesterol (HDL-C) (HDL-C). It is also approved for paediatric patients aged 8 and up with heterozygous familial hypercholesterolemia (HeFH) to lower elevated TC, LDL-C, and Apo B.
The drug will be produced at the group’s Moraiya formulation manufacturing facility. Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg had annual sales in the United States of USD 319 million (IQVIA MAT Dec. 2022)