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Sold as Scemblix. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Asciminib Hydrochloride (sold as Scemblix), first approved Oct 29, 2021, with 5 new uses approved and 0 published complete response letters.
First approved: Oct 29, 2021
Applications: 1
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $468M
Orphan exclusivity until: Oct 29, 2031
First approved in the EU: Aug 25, 2022
First approved in Japan: Mar 28, 2022
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 5 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ScemblixDrugs with a new indication and a new dosage for the treatment of chronic myelogenous leukemia. · Novartis Pharma K.K. · May 19, 2025
Scemblix, new ingredientDrugs with a new active ingredient indicated for the treatment of chronic myelogenous leukemia with resistance or intolerance to prior drug therapies. · Novartis Pharma K.K. · Mar 28, 2022
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
Novartis