FDA Approves First Generic Version of Crestor

The FDA has approved the first generic version of rosuvastatin calcium (Crestor) tablets.

The tablets may be used to treat adult patients’ hypertriglyceridemia, as well as adults with homozygous familiar hypercholesterolemia either alone or in combination with other cholesterol treatments. In addition, Crestor can be used in combination with diet for treating primary dysbetalipoproteinemia.

“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, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, in a press release. “The FDA requires that generic drugs meet rigorous scientific and quality standards.”

In clinical trials for Crestor, the most common adverse effects among the patients taking the drug were headache, pain in muscles, abdominal pain, weakness, and nausea.

Pharmacists can help remind patients that Crestor should not be used in pregnant women or women who may become pregnant. In addition, women taking rosuvastatin should not nurse their infants.

Watson Pharmaceuticals received FDA approval to market the tablets in multiple strengths.