www.fdanews.com/articles/86291-aurobindo-gets-tentative-fda-approval-for-simvastatin
AUROBINDO GETS TENTATIVE FDA APPROVAL FOR SIMVASTATIN
April 24, 2006
India's Aurobindo Pharma has received a tentative approval from the FDA for simvastatin, a medicine used to lower the level of cholesterol.
The tentative approval is for 5 mg, 10 mg, 20 mg, 40 mg and 80 mg tablets. Simvastatin is a generic version of Merck's blockbuster medicine Zocor, which has estimated annual sales of $5 billion in the U.S.