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FDA Approves Generic Form of Zocor

June 24, 2006

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The Food and Drug Administration has approved the first generic version of Zocor, a popular statin that reduces cholesterol in the bloodstream. The agency says it's an important step in its efforts to increase the availability of lower-cost generics.

Simvastatin, the generic name for Zocor, is recommended for use along with a diet restricted in saturated fat and cholesterol to treat high cholesterol and to reduce the amount of certain triglycerides and other lipids.

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

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

Simvastatin Tablets (5 mg, 10 mg, 20 mg and 40 mg) are manufactured by IVAX Pharmaceuticals, Inc. (IVAX) of Northvale, New Jersey and simvastatin tablets (80 mg) are manufactured by Ranbaxy Pharmaceuticals, Inc. of Princeton, New Jersey.

In addition to Simvastatin, FDA recently approved the following first generic products:

• Finasteride Tablets, 1 mg (Propecia) - for the treatment of mild to moderate male pattern hair loss in men between 18-41 years of age.

• Finasteride Tablets, 5 mg, (Proscar) - for the treatment of benign prostatic hypertrophy (BPH) in men with an enlarged prostate to improve symptoms by reducing the size of the prostate.

• Lamotrigine Tablets (Chewable), 5 mg and 25 mg (Lamictal) - therapy for treating patients with seizures due to epilepsy.

The economic benefits of FDA's generic drug approval program are significant because generics can cost a fraction of the price of the brand name drugs and generic drugs represent about two-thirds of total prescription doses sold in the U.S. in 2004, according to IMS data on U.S. retail sales.

Competition from these four generics and from future generics that are substitutable for these products may quickly lead to reductions in spending of about $1 billion per year, the FDA said.

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