New Delhi : Drug firm Lupin has received tentative approval from the US health regulator to market its cholesterol lowering Pitavastatin tablets in the American market.
The firm has received tentative approval from United States Food and Drug Administration to market its Pitavastatin tablets in the strength of 1mg, 2 mg and 4 mg, Lupin said in a filing to BSE. The tablets are generic versions of Kowa’s Livalo tablets in the same strengths, it added.
As per IMS MAT September 2016 data Livalo tablets had US sales of $245.3 million, Lupin said. “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,” it added.