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FDA approves first generic rosuvastatin
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The FDA has approved the first generic rosuvastatin calcium tablets for the treatment of high triglycerides and high LDL, according to a press release.
Watson Pharmaceuticals Inc. has been approved to market the generic rosuvastatin calcium in multiple strengths, according to the release. The drug was previously available only under the brand name Crestor (AstraZeneca).
“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,” Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in the release.
The rosuvastatin calcium tablets have been approved specifically for use in combination with diet for treatment of hypertriglyceridemia in adults, in combination with diet for treatment of Type III hyperlipoproteinemia and either alone or in combination with other cholesterol treatments for adult patients with homozygous familial hypercholesterolemia.
The drug is contraindicated in pregnant women and women who may become pregnant.
“The FDA requires that generic drugs meet rigorous scientific and quality standards,” said Uhl.
Reference: Uhl is an employee of the FDA.