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www.fdanews.com/articles/69512-ivax-receives-final-approval-for-cilostazol-tablets

Ivax Receives Final Approval for Cilostazol Tablets

March 7, 2005

The FDA has approved Ivax's abbreviated new drug application for cilostazol tablets, 100 mg. Cilostazol is the generic equivalent of Otsuka American Pharmaceutical's Pletal tablets.

Ivax said the product will be sold through its Ivax Pharmaceuticals subsidiary. Cilostazol tablets are used to treat intermittent claudication, pain in the legs that happens when walking and goes away with rest. U.S. sales of 100-mg cilostazol tablets were $154.2 million in 2004, according to IMS Health data.