Lupin received approval from the U.S. FDA for its ANDA for Pitavastatin Tablets to market a generic equivalent of Livalo Tablets of Kowa Company Limited.
Global pharma major Lupin Limited (Lupin) today 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, 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 September2023).
