Bangalore, Feb 08, 2010: Indian pharma major, Lupin said that the US Food and Drug Administration (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, Mr Nilesh Gupta, Group President and Executive Director of Lupin Limited, said, “This is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line. The approval reflects the confidence and acceptance of our facility by the FDA.”