Lupin launches additional strength of generic Lotrel capsules

Pharma major, Lupin’s subsidiary - Lupin Pharmaceuticals Inc (LPI) has been granted the final approval by the United Food & Drug Administration (USFDA) for the company’s abbreviated drug application (ANDA) for Amlodipine/ Benazepril 5mg/40mg and 10 mg/40 mg capsules. The commercial shipments of the products have commenced.

This approval completes the product line as the company was granted final approval for Amlodipine/Benazepril 2.5 mg/ 10 mg, 5mg/10mg, 5mg/20 mg and 10 mg/20 mg capsules in February 2010.

Lupin’s Amlodipine/ Benazepril capsules are the AB rated generic equivalents of the Novartis Lotrel capsules indicated for the treatment of hypertension. Amlodipine/ Benazepril 5mg/40mg and 10 mg/40 mg capsules had annual sales of approximately $290 million for the twelve months ended March 2011.