Pharma Major Lupin has received tentative approval for its Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Kowa Company’s Livalo Tablets 1 mg, 2 mg and 4 mg. The filing is from company’s Pithampur (Indore) manufacturing facility.
The company’s Pitavastatin Tablets, 1 mg, 2 mg and 4 mg are the AB rated generic equivalent of Kowa's Livalo Tablets, 1 mg, 2 mg and 4 mg. Pitavastatin Tablets are indicated as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Livalo Tablets had US sales of $245.3 million as per IMS MAT Sep 2016.
Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.
