Zydus Lifesciences gets USFDA nod to market generic drug to lower cholesterol levels

Zydus Lifesciences on Friday said it has received an approval from the US health regulator to market a generic medication to lower high cholesterol levels.

The company has received final approval from the US Food and Drug Administration to market Pitavastatin tablets in strengths of 1 mg, 2 mg, and 4 mg, the drug maker said in a statement. The company’s product is the generic equivalent of 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 in Gujarat, the company stated. As per IQVIA MAT Dec data, Pitavastatin tablets (1 mg, 2 mg, and 4 mg) had annual sales of USD 319 million in the US. Shares of the company settled 0.24 per cent down at Rs 466.80 apiece on the BSE.