Generic Crestor Approved by FDA

From the WebMD Archives

April 29, 2016 -- The first generic version of the cholesterol-lowering statin drug Crestor (rosuvastatin calcium) tablets was approved Friday by the U.S. Food and Drug Administration.

The generic version from Watson Pharmaceuticals Inc. of New Jersey received approval to market generic rosuvastatin calcium in multiple strengths for certain uses

These include:

  • in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults
  • in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides
  • either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high levels of "bad" low-density lipoprotein (LDL) cholesterol.

High LDL cholesterol is a risk factor for heart disease, heart attack and stroke. High triglycerides may also increase the risk of heart disease, the FDA said.

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