Livalo (pitavastatin tablets, from Kowa Pharmaceuticals) has been FDA approved for the primary treatment of hypercholesterolemia and combined dyslipidemia.  This approval is based on Phase 3 trials, where it was demonstrated that Livalo effectively reduced LDL-C and improved other parameters of lipid metabolism in special patient populations, including the elderly, patients with diabetes and patients at higher cardiovascular risk.

Livalo is a HMG-CoA reductase inhibitor (statin) with a cyclopropyl group on its base structure.  This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol.

LIVALO is expected to launch in the U.S. during the first quarter of 2010 and will be available in dosage strengths of 1 mg, 2 mg and 4 mg.

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