Lupin Receives US FDA Approval for Simvastatin Tablets

Lupin Ltd on May 15, 2007 has announced that it has received final approval from the US FDA for it's Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.

The Company's Simvastatin Tablets are the AB-rated generic equivalent of Merck's Zocor® tablets. Simvastatin is indicated for the treatment of high cholesterol.

'The approval of our Simvastatin ANDA marks our entry in the finished dosages market for the widely prescribed class of lipid modifying drugs. The launch of Simvastatin will further expand our generic portfolio,' said Dr. Kamal Sharma, Managing Director, of the Company.

With this approval, the Company now has 21 ANDAs approved by the US FDA.

Source : Equity Bulls

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