FDA Approves Pitavastatin for Hyperlipidemia, Mixed Dyslipidemia
Pitavastatin is an HMG Co-A reductase inhibitor.
Lupin announced that the Food and Drug Administration (FDA) has approved Nikita (pitavastatin), an HMG Co-A reductase inhibitor, for the treatment of primary hyperlipidemia or mixed dyslipidemia as an adjunct to diet to reduce elevated total cholesterol, LDL, apolipoprotien B, triglycerides, and to increase HDL. Nikita is an alternative version of Livalo® (pitavastatin calcium; Kowa) tablets.
The efficacy of pitavastatin has been evaluated in multiple clinical studies including: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study (n=251) to evaluate the efficacy of pitavastatin vs. placebo; a Phase 3 non-inferiority study (n=817) to compare pitavastatin to atorvastatin; a Phase 3 non-inferiority study (n=843) to compare pitavastatin to simvastatin; a Phase 3 non-inferiority study (n=942) to compare pitavastatin to pravastatin; a Phase 3 study (n=351) to compare pitavastatin to simvastatin in patients with at least two risk factors for coronary heart disease; and a Phase 3 study (n=410) to compare pitavastatin to atorvastatin in patients with type 2 diabetes mellitus and combined dyslipidemia.
Nikita will be available as 1mg, 2mg, and 4mg strength tablets in 30-, 60-, and 90-count bottles.
Lupin receives FDA approval for Nikita™ (pitavastatin) tablets [news release]. Mumbai, India: Pharma Major Lupin Limited. http://www.lupin.com/lupin-receives-fda-approval-for-nikitatm-pitavastatin-tablets.php. Published August 9, 2017. Accessed September 1, 2017.