FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules.  Commercial shipments of the product have already commenced.

Lupin's Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis' Lotrel® capsules indicated for the treatment of hypertension. Amlodipine/Benazepril had annual sales of approximately $1.1 billion for the twelve months ended September 2009, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc., said, "We are very pleased with the approval of our Amlodipine/Benazepril capsules.  This is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line."  Ms. Gupta added, "The approval reflects the confidence and acceptance of our facility by the FDA, as well as our unwavering commitment to quality and to bringing important products to market."