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India's Aurobindo Pharma gets tentative FDA approval for Simvastatin |
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25 Apr 2006 |
MUMBAI, INDIA | Apr 24, 2006 | India's Aurobindo Pharma Ltd. (524804.BY) said Monday it has received a tentative approval from the U.S. Food & Drug Administration for simvastatin, a medicine used to lower the level of cholesterol.
The tentative approval is for 5 milligram, 10 mg, 20 mg, 40 mg and 80 mg tablets, said Aurobindo in a notice to the stock exchange.
Simvastatin is a generic version of Merck & Co. Inc.'s (MRK) branded blockbuster medicine Zocor, which has estimated annual sales of $5 billion in the U.S.
Aurobindo said it makes both the main drug ingredient and the finished drug.
SOURCE: Aurobindo Pharma Ltd |
