Zydus Life gets final USFDA nod for cholesterol drug

Zydus Lifesciences said that it has received final approval from the US Food and Drug Administration (USFDA) for Pitavastatin tablets.

The said drug is equivalent to reference listed drug, 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).

The tablets are 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.

According to IQVIA MAT sales data for the 12 month period ending 31 December 2022, Pitavastatin tablets had annual sales of $319 million in the United States.

As of 31 December 2022, the Zydus Group has total 345 approvals and filed over 440 ANDA's since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is engaged in an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The product portfolio of the company includes active pharmaceutical ingredients [API] and human formulations.

The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.

The scrip shed 0.24% to end at Rs 466.80 on the BSE.

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