Lupin gets USFDA’s approval for Pitavastatin Tablets

21 Nov 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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. 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; and Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin Tablets (RLD Livalo) had estimated annual sales of $298 million in the U.S. (IQVIA MAT September 2023). 

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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