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FDA NEWS RELEASE

For Immediate Release: August 3, 2009

Media Inquiries: Pat El-Hinnawy, 301-796-4763; patricia.el-hinnawy@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Cholesterol-Lowering Drug

The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Statins improve elevated blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.

"Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke," said Eric C. Colman, M.D., deputy director, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.

The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

Livalo is manufactured by Kowa Pharmaceuticals America Inc. of Montgomery, Ala.

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