Like other statins, Livalo is intended for patients when diet and exercise fail to lower their
"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.
Source
U.S. Food and Drug Administration