FDA Permits Last-Resort Iclusig Use After Clinical Trial Deaths

Law360, New York (December 20, 2013, 7:04 PM EST) -- Two months after announcing a spate of deaths, the U.S. Food and Drug Administration on Friday allowed Ariad Pharmaceuticals Inc. to resume sales of leukemia drug Iclusig to a narrower universe of patients who will receive stronger warnings about the product’s serious risks.

The return comes after at least 14 people died while taking Iclusig in clinical trials that were intended to get a fuller picture of the drug’s safety and effectiveness after it received fast-track approval last year to treat two rare types of leukemia. The...
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