New Delhi: 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.
As per IMS MAT June 2017 data, Livalo tablets had US sales of USD 272 million, it added.