Pharma major, Lupin announced that the US Food and Drug Administration (US 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' Lorrel capsules indicated for the treatment of hypertension. amlodipine/benazepril had annual sales of approximately US$ 1.1 billion for the twelve months ended September 2009, based on IMS Health sales data.
Commenting on the approval, Nilesh Gupta, Group president and executive director of Lupin Limited, 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,” Gupta added. “The approval reflects the confidence and acceptance of our facility by the US FDA, as well as our unwavering commitment to quality and to brining important products to market.”