FDA OKs 1st Generic Version of Zocor
Generic Simvastatin to Target High Cholesterol for Less
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 cholesterolhigh cholesterol (hypercholesterolemia) and to reduce blood levels of certain fatty substances, such as triglyceridestriglycerides.
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.