Zydus Lifesciences gets FDA final approval for Pitavastatin Tablets
Zydus Lifesciences said that it has bagged final approval for Pitavastatin Tablets, 1mg, 2mg, and 4mg from the US Food and Drug Administration (FDA).
Pitavastatin Tablets is the generic version of Livalo Tablets, which is a HMG-CoA reductase inhibitor. It has approval as an adjunctive therapy to diet in adults having primary hyperlipidemia or mixed dyslipidemia to lower increased total cholesterol (TC), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and to boost high-density lipoprotein cholesterol (HDL-C).
Zydus Lifesciences gets FDA final approval for Pitavastatin Tablets. Photo courtesy of Zydus Cadila.
It is also approved for pediatric patients aged eight and over having heterozygous familial hypercholesterolemia (HeFH) to lower elevated TC, Apo B, and LDL-C.
Zydus Lifesciences will manufacture Pitavastatin Tablets at its formulation manufacturing facility at Moraiya, Gujarat.
According to IQVIA MAT December 2022, Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg had annual sales of $319 million in the US.