FDA tentatively approves Aurobindo's Simvastatin for high cholesterol

By Lisa Kerner

Erie, Pa., April 24 - Aurobindo Pharma Ltd. said the Food and Drug Administration has granted tentative approval for the company's Simvastatin Tablets USP (5 mg, 10 mg, 20 mg, 40 mg and 80 mg) for the treatment of high cholesterol.

Simvastatin is the generic form of Merck's Zocor, the second-largest brand in the United States with sales of more than $5 billion annually.

Aurobindo, based at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.

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