Watson Pharmaceuticals, Inc. has announced that its subsidiary, Watson Laboratories, Inc. – Florida, has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release tablets, the generic equivalent to Biovail Laboratories International SRL’s Cardizem® LA product. Watson intends to launch its generic version of Cardizem® LA immediately.
Diltiazem Hydrochloride Extended-Release tablets are indicated for the treatment of hypertension. For the 12-months ending December 31, 2009, Cardizem® LA had total U.S. sales of approximately $94.1 million, according to IMS Health.