Zydus Lifesciences Limited 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 USD 319 mn 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.
