From Our 2006 Archives

FDA OKs 1st Generic Version of Zocor

Generic Simvastatin to Target High Cholesterol for Less

ByMirandaHitti
WebMD Medical News

Reviewed ByLouiseChang,MD
on Friday, June 23, 2006

June 23, 2006 -- The first generic version of the cholesterol-lowering statin drug Zocor has been approved by the FDA.

The new generic, simvastatin, is recommended for use along with a diet restricted in saturated fat and cholesterol to treat high cholesterol (hypercholesterolemia) and to reduce blood levels of certain fatty substances, such as triglycerides.

In 2005, statins accounted for more than $16 billion in U.S. sales, and Zocor was the second most widely prescribed statin, according to the research firm IMS Health.

"This approval is another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits," says Gary J. Buehler, who directs the Office of Generic Drugs, in an FDA news release.

"Simvastatin is a widely used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease," Buehler adds.

Generic simvastatin tablets are made in doses of 5 milligrams, 10 milligrams, 20 milligrams, and 40 milligrams by IVAX Pharmaceuticals, Inc. Generic 80-milligram simvastatin tablets are made by Ranbaxy Pharmaceuticals Inc.

Zocor is made by the drug company Merck, a WebMD sponsor.

SOURCES: News release, FDA. IMS Health: "Commonly Requested Therapeutic Class and Product Information (update February 2006)."

© 2006 WebMD Inc. All rights reserved