Lupin Limited on Tuesday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg.
The approval has been granted to market a generic equivalent of Livalo Tablets, 1 mg, 2 mg, and 4 mg, of Kowa Company Limited. The product will be manufactured at Lupin’s Pithampur facility in India.
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
- Adults with primary hyperlipidemia.
- Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Pitavastatin Tablets (RLD Livalo) had estimated annual sales of USD 298 million in the U.S. (IQVIA MAT September 2023).
