FDA Approves Watson’s Generic of Cardizem LA

March 19, 2010, 4:00 AM UTC

The Food and Drug Administration approved Watson Laboratories Inc.'s abbreviated new drug application for a generic version of Biovail Corp.'s Cardizem LA (diltiazem hydrochloride extended-release tablets), Watson Pharmaceuticals Inc. announced March 15.

Watson said it immediately will begin selling the drug, which is indicated for the treatment of hypertension. Watson and Biovail in December 2007 announced they settled long-running patent litigation over the generic version of Cardizem LA (5 PLIR 1265, 12/7/07).

In a press release, Watson cited IMS Health data that showed Cardizem LA’s sales in the United States were $94.1 million in 2009.

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