Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+…. Sold as Danziten. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Nilotinib Tartrate (sold as Danziten), first approved Nov 7, 2024, with 0 new uses approved and 0 published complete response letters.
First approved: Nov 7, 2024
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $9.5M
Orphan exclusivity until: Sep 23, 2028
First approved in the EU: Nov 19, 2007
First approved in Japan: Jan 21, 2009
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 190 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
TasignaDrugs with a new pediatric dosage indicated for the treatment of chronic- or accelerated-phase chronic myeloid leukemia. · Novartis Pharma K.K. · Dec 25, 2017
Tasigna, new approvalDrugs with new additional indications and a new dosage for the treatment of chronic- or accelerated-phase chronic myelocytic leukaemia. · Novartis Pharma K.K. · Dec 21, 2010
Tasigna, new ingredientA drug containing a new active ingredient indicated for the treatment of imatinib-resistant, chronic phase and accelerated phase chronic myelogenous leukemia. · Novartis Pharma K.K. · Jan 21, 2009
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
