Watson Laboratories receives FDA approval for Amlodipine capsules

Watson Pharmaceuticals, Inc. (NYSE: WPI), today 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 U.S. sales of approximately $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.