Watson Pharmaceuticals, Inc announced that its subsidiary, Watson Laboratories, Inc, has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules, the generic equivalent to Novartis' Lotrel capsules. The ANDA was acquired as part of Watson's acquisition of the Arrow Group. Watson intends to begin shipping the product immediately.
Lotrel capsules and its generic equivalents had total US sales of approximately US$ 1.05 Billion for the twelve months ending June 30, 2010, according to IMS Health. Amlodipine Besylate/Benazepril capsules are indicated to prevent and treat high blood pressure.