The U.S. Food and Drug Administration (FDA) announced the approval of the first generic version of Crestor (rosuvastatin calcium) last week.
Watson Pharmaceuticals Inc. will market the generic drug in various strengths.
The generic is approved for three uses: to treat high triglycerides, primary dysbetaliproteinermia and homozygous familial hypercholesterolemia. The first two conditions require treatment with rosuvastatin calcium in combination with diet while the third allows the generic to be used alone or in combination with other treatments for cholesterol. High triglycerides and LDL cholesterol are associated with heart disease. LDL cholesterol is also known as a risk factor in heart attacks and strokes.
“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,” FDA's Director of the Office of Generic Drugs Dr. Kathleen Uhl said. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”
Generic drugs are required to have the same quality and strength as the equivalent brand-name drug. The manufacturers of generics are held to the same high standards as the original manufacturer. The FDA must approve a generic drug before it is released to pharmacists, health care providers and the public.