The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses: 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 low-density lipoprotein (LDL) cholesterol.
Watson Pharmaceuticals Inc. of Parsippany, New Jersey has received approval to market generic rosuvastatin calcium in multiple strengths.
Rosuvastatin calcium is in a class of drugs called statins, which work by stopping an enzyme called HMG-CoA reductase from making cholesterol. Statins should be used in addition to a diet restricted in saturated fat and cholesterol. In the clinical trials for Crestor, the most common side effects reported by participants taking Crestor included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.
