Lupin Receives US FDA Approval For Amlodipine Capsules (08-Feb-2010)
Pharma major, Lupin Ltd announced today that the US Food and Drug Administration (US FDA) has granted final approval for its Amlodipine/Benazepril 2,5mg/10mg, 5mg/10mg, 5mg/20ing and 10nig/2()mg capsules. Commercial shipments of the product have already commenced.
Lupin''s Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis'' I/jtrel® capsules indicated for the treatment of hypertension. Amlodipine/Benazcpril 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, Nflesh Gupta, Group President and Executive DirecLor of Lupin Limited, said, "We are very pleased with the approval of our Amlodipine/Benazepril capsules, ITiis is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line." Mr, Gupta added, "The approval reflects the confidence and acceptance of our facility by die FDA, as well as our unwavering commitment to quality'' and to bringing important products to market."
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