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Iclusig FDA Approval History

FDA Approved: Yes (First approved December 14, 2012)
Brand name: Iclusig
Generic name: ponatinib
Dosage form: Tablets
Company: Ariad Pharmaceuticals, Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia

Iclusig (ponatinib) is a kinase inhibitor for the treatment of chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

Development Timeline for Iclusig

Dec 14, 2012Approval FDA Approves Iclusig to Treat Two Rare Types of Leukemia
Oct 24, 2012ARIAD Announces U.S. Food and Drug Administration Acceptance of NDA Filing for Ponatinib
Aug 13, 2012Ariad Announces Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration

Further information

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