First generic version of Crestor gets FDA approval

Apr 30 2016

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.

High LDL cholesterol, the so-called "bad cholesterol," is a known risk factor for heart attacks, strokes, and heart disease. High triglycerides may also increase the risk of heart disease.

"The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments," said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "The FDA requires that generic drugs meet rigorous scientific and quality standards."

Generic drugs approved by the FDA have the same quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

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.

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.