Lupin Pharmaceuticals, Inc. has announced that it has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Simvastatin Tablets 10mg, 20mg, 40mg and 80mg.
Lupin's Simvastatin Tablets are the AB-rated generic equivalent of Merck's Zocor(R) tablets. Simvastatin is indicated for the treatment of high cholesterol.
Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. commented, "We are delighted to receive final FDA approval for Simvastatin Tablets. The addition of generic Zocor(R) complements Lupin's commitment to bringing high-quality, low cost drug alternatives to the American public."
With this approval, Lupin now has 21 ANDAs approved by the US FDA.