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These highlights do not include all the information needed to use DANZITEN safely and effectively. See full prescribing information for DANZITEN. DANZITEN (nilotinib) tablets, for oral use Initial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
DANZITEN is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. DANZITEN is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna® (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
- generic_name
- nilotinib
- product_names
- nilotinib
- ndc
- 24338-154, 24338-154-03, 24338-154-02, 24338-154-01, 24338-155, 24338-155-03, 24338-155-02, 24338-155-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en