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Label Changes for:

Sprycel (dasatinib) Tablets

June 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –


June 2013



(Clinical Trials section revised of the package insert to include information from interim follow-up analyses of data coming from the ongoing Phase 3 studies CA180034 (with a minimum of 5 years follow-up) and CA180056 (with a minimum of 3 years follow-up).