Lilly, Kowa release new statin in U.S.

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Kowa Pharmaceuticals America and Eli Lilly have made available Livalo (pitavastatin) tablets in U.S. retail pharmacies.

Livalo, a statin medication approved by the FDA in August 2009, is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. Livalo is available in doses of 1 mg, 2 mg and 4 mg.

Livalo, approved on the basis of 10 clinical trials, including five 12-week clinical trials comparing efficacy and safety to three currently FDA-approved statins (atorvastatin, simvastatin and pravastatin), offered LDL cholesterol lowering of up to 39 percent at a 2 mg dose and up to 45 percent at a 4 mg dose, reported the Montgomery, Ala.-based Kowa and the Indianapolis-based Lilly.