Zydus receives final approval from the USFDA for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg

Zydus Lifesciences Limited (including its subsidiaries / affiliates hereafter referred to as "Zydus") 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.

Shares of Cadila Healthcare Limited was last trading in BSE at Rs. 466.80 as compared to the previous close of Rs. 467.90. The total number of shares traded during the day was 33174 in over 1453 trades.

The stock hit an intraday high of Rs. 471.55 and intraday low of 461.30. The net turnover during the day was Rs. 15453773.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals FinalApproval USFDA PitavastatinTablets