Ariad Pharmaceuticals Inc. Dec. 20, 2013, announced that the Food and Drug Administration has approved revised prescribing information and a risk evaluation and mitigation strategy (REMS) for Iclusig (ponatinib) that allows immediate resumption of the drug’s marketing and commercial distribution.
In October 11 PLIR 1317, 11/1/13, the FDA said that Ariad had agreed to suspend marketing and sales of the chemotherapy drug Iclusig “because of the risk of life-threatening blood clots and severe narrowing of blood vessels.”
The prescribing information includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers, the ...
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