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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) is providing instructions to health care professionals whose patients have been taking Iclusig (ponatinib) and are benefiting from the drug, on how to continue those patients on the drug. We are working closely with Iclusig’s manufacturer, ARIAD Pharmaceuticals (ARIAD), to avoid interruptions in treatment. At this time, Iclusig treatment may be continued for appropriate patients under an emergency Investigational New Drug (IND) application.
Health care professionals (HCPs) may continue to use Iclusig for patients who they determine are responding to the drug and for whom the potential benefits outweigh the risks. As stated previously, HCPs should immediately discontinue Iclusig treatment for patients who are not responding to the drug and discuss alternative treatment options with them. New patients should not be started on Iclusig unless no other treatment options are available and all other available therapies have failed.
For more information please visit: Iclusig
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