Pharma major, Lupin Limited announced that its US subsidiary, Lupin Pharmaceuticals, Inc. LPI has been granted final approval by the United States Food and Drugs Administration for the company's Abbreviated New Drug Application (ANDA) for Amlodipine/Benazepril 5mg/40mg, and 10mg/40mg capsules. Commercial shipment of the product has commenced.
This approval completes the product line as the company was granted final approval for Amlodipine Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules in February 2010.
Lupin's Amlodipine / Benazepril capsules are the AB-rated generic equivalent of Novartis Lotrel capsules indicated for the treatment of hypertension. Amlodipine / Benazepril 5mg/40mg, and 10mg/40mg capsules had annual sales of approximately $290 million for the twelve months ended March 2011.