Lupin gets USFDA nod for Pitavastatin tablets

Drug firm Lupin has received tentative approval from the US health regulator to market its cholesterol lowering Pitavastatin tablets in the American market.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market its Pitavastatin tablets in the strength of 1 mg, 2 mg and 4 mg, Lupin said in a filing to BSE.

The company's 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 USD 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.
 

Shares of Lupin Ltd today closed at Rs 1,483.70 per scrip on BSE, up 1.19 per cent from its previous close.