FDA Gives Nod for Generic Drug Pitavastatin To Lower Cholesterol Levels

Zydus (formally known as Cadila) Lifesciences Limited has received approval from the US Food and Drug Administration (FDA) to market a generic medicine named Pitavastatin to lower high cholesterol levels.

Under this approval, the medicine Pitavastatin will be marketed in strengths of 1 mg, 2 mg, and 4 mg tablets. This medicinal product (Pitavastatin) by Zydus is the generic alternative to Livalo tablets.

What is Pitavastatin:

Pitavastatin falls under the class of drugs known as HMG-CoA reductase inhibitors. The medicine is used as adjunctive therapy to diet in adult individuals with primary hyperlipidemia (a condition in which there are excess fat particles or lipids in the blood) or mixed dyslipidemia (a lipoprotein metabolism disorder) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to enhance high-density lipoprotein cholesterol (HDL-C).

The medicine is also approved for pediatric patients aged 8 years or more with heterozygous familial hypercholesterolemia (HeFH) to scale down the elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B).

The company stated that the generic Pitavastatin will be manufactured at Moraiya in Gujarat, which is the group`s formulation manufacturing facility.

Reference:

https://health.economictimes.indiatimes.com/news/pharma/zydus-lifesciences-gets-usfda-nod-to-market-generic-drug-to-lower-cholesterol-levels/98213836