FDA approves Kowa Pharmaceuticals’ statin
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for lowering cholesterol.
The FDA announced Monday the approval of Livalo (pitavastatin), manufactured by Montgomery, Ala.-based Kowa Pharmaceuticals.
Like other statins, the drug is designed for patients for whom diet and exercise have failed to lower cholesterol levels. Statins lower cholesterol by inhibiting HMG Co-A reductase, a liver enzyme involved in the liver’s manufacture of cholesterol.
“Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke,” FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products deputy director Eric Colman said in a statement. “Today’s approval offers patients and their healthcare professionals another alternative way to treat high cholesterol.”