Lupin receives USFDA nod for cholesterol drug

PTI New Delhi | Updated on January 09, 2018 Published on August 09, 2017


Drug firm Lupin has received approval from the US health regulator to market Pitavastatin tablets used for lowering cholesterol.

In a BSE filing, Lupin said it has received 505 (b) (2) NDA approval for its Nikita Pitavastatin tablets 1mg, 2mg and 4mg from the United States Food and Drug Administration (USFDA).

The company said Nikita tablets are Pitavastatin sodium, an alternate salt product of Kowa Company Ltd’s Livalo tablets.

“It is a new option for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunction therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotien B, triglycerides and to increase high-density lipoprotein cholesterol,” it said.

According to IMS MAT June 2017 data, Livalo tablets had US sales of $272 million, it added.

Shares of Lupin Ltd were trading at Rs 961.95 per scrip in morning trade on BSE, down 1.28 per cent down from its previous close.

Published on August 09, 2017
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