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FDA Approves First Generic Simvastatin
Third New Generic Approved This Week

The Food and Drug Administration today approved the first generic version of Zocor® (simvastatin), an important step in the agency's effort to increase the availability of lower-cost generic medications.

Simvastatin is recommended for use along with a diet restricted in saturated fat and cholesterol to treat hypercholesterolemia (high cholesterol) and to reduce the amount of certain fatty substances in the blood such as triglycerides and other lipids. According to the research firm, IMS Health, statins accounted for $16 billion in U.S. sales in 2005. 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."

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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 today's approval of Simvastatin, FDA approved the following first generic products earlier this week:

• 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. This estimate of savings assumes each drug attracts only two generic competitors and these competitors would capture about 50% of the brand name sales. The savings would likely increase as more competitors enter the market (See http://www.fda.gov/cder/ogd/generic_competition.htm.)

The Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications as quickly as possible. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm

For additional information related to FDA's Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.