Article Content

Simvastatin, the generic version of Zocor, was recently approved by the Food and Drug Administration for use. Simvastatin is recommended for use to treat hypercholesterolemia (high cholesterol) along with a diet restricted in saturated fat and cholesterol. Statins accounted for $16 billion in US sales in 2005, according to the research firm IMS Health. Zocor was the second most widely prescribed statin.

 

Gary J. Buehler, Director of the Office of Generic Drugs said, "Simvastatin is a widely-used cholesterol lowering agent, and its generic version can bring significant cost savings to the millions of Americans with this disease."

 

Simvastatin is distributed in tablet form (5 mg, 10 mg, 20 mg, and 40 mg) and are manufactured by IVAX Pharmaceuticals, Inc. of Northvale, New Jersey, and the 80-mg tablets are manufactured by Ranbaxy Pharmaceuticals, Inc., of Princeton, New Jersey.

 

The FDA's approval of generics is significant because these drugs can cost a fraction of the price of the brand-name drugs. In 2004, generic drugs represented about two thirds of the total prescription doses sold in the United States. The Office of Generic Drugs continues to work quickly to review and take action on generic drug applications. If you want to know more about other first generic versions, log on to the following Web sites: http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm

 

REFERENCE

 

U.S. Food and Drug Administration Web site: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01394.html