Watson Pharmaceuticals, Inc., today announced that its subsidiary,
Watson Laboratories, Inc., has received approval from the FDA 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