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news.India-based Lupin Pharmaceuticals has been granted final approval for its abbreviated new drug application for trandolapril tablets, 1mg, 2mg and 4mg, for the treatment of hypertension. Commercial shipments of Trandolapril tablets has commenced.
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Lupin's trandolapril tablets are the AB-rated generic equivalent of Abbott's Mavik tablets, indicated for the treatment of hypertension. The brand product had annual sales of approximately $49 million for the twelve months ended December 2006, based on IMS sales data.
Commenting on the approval, Vinita Gupta, president and MD of Lupin Pharmaceuticals, said: “This approval broadens our growing portfolio of cardiovascular medications, and we look forward to offering this cost-effective alternative to patients in the US.”