Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its Nikita™ (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).
Lupin's Nikita™ (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg are Pitavastatin Sodium, an alternate salt product of Kowa Company Ltd's Livalo® (Pitavastatin Calcium) Tablets.
It is a new option for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low- density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol.
Livalo® Tablets had US sales of USD 272 million (IMS MAT June 2017).
