Zydus Lifesciences Receives Nod From USFDA For Pitavastatin Tablets
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 equivalent to US Reference Listed Drug: Livalo Tablets, the company said in a regulatory filing on Friday.
Pitavastatin is an HMG-CoA reductase inhibitor indicated as 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, the company's statement read.
Pitavastatin Tablets had annual sales of USD 319 mn in the United States as per IQVIA MAT December. 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. The company's stock closed 0.24 per cent lower on Friday at Rs 466.80 per scrip.
