Lupin announces FDA approval of Trandolapril tablets

Jun 17 2007

Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Trandolapril Tablets, 1mg, 2mg and 4mg. Commercial shipments of Trandolapril tablets have commenced.

Lupin's Trandolapril Tablets are the AB-rated generic equivalent of Abbott's Mavik(R) 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 Managing Director of Lupin Pharmaceuticals, Inc. said, "We are delighted with the timely approval of Trandolapril tablets." Ms. Gupta added, "This approval broadens our growing portfolio of cardiovascular medications, and we look forward to offering this cost-effective alternative to patients in the U.S."