What is Rosuvastatin?
Rosuvastatin, marketed as Crestor®, is a member of the drug class of statins, used in combination with exercise, diet, and weight-loss to treat high cholesterol and related conditions, and to prevent cardiovascular disease.
It was developed by Shionogi. In 2013 Crestor® was the fourth-highest selling drug in the United States, accounting for approx. $5.2 billion in sales. A generic version became available in the United States in 2016.
FDA approves first generic Crestor®
For Immediate Release: April 29, 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.