Drug Information Update- FDA approves first generic Crestor (rosuvastatin calcium)

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

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.

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.

Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm. Women who require treatment with rosuvastatin should be advised not to nurse their infants.

For more information, please visit: rosuvastatin.