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First Generic Version of Simvastatin Gets FDA Approval

Generic versions also approved for Proscar, Propecia and Lamictal

MONDAY, June 26 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generic version of simvastatin (Zocor), the second most widely prescribed statin in the United States, to treat hypercholesterolemia. The FDA also recently approved generic versions of Proscar, Propecia and Lamictal.

The drug is currently manufactured by IVAX Pharmaceuticals Inc., in 5 mg, 10 mg, 20 mg and 40 mg doses; and by Ranbaxy Pharmaceuticals Inc., of Princeton, N.J., in an 80 mg formulation.

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

According to research firm IMS Health, generic drugs account for approximately two-thirds of all drug sales in the United States and the introduction of these four new drugs may save $1 billion a year in drug costs.

The other FDA approvals were for finasteride tablets, 1 mg (Propecia), used to treat hair loss; finasteride tablets, 5 mg (Proscar), used for the treatment of benign prostatic hypertrophy; and lamotrigine tablets, 5 mg and 25 mg (Lamictal), for treatment of epileptic seizures.

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