Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg (USRLD: Livalo Tablets).
Pitavastatin is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). It is also indicated for pediatric patients aged 8 years or older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg had annual sales of $319 million in the United States (IQVIA MAT Dec. 2022). The group now has 345 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
