Treats intermediate-2 or high-risk primary or secondary (post-polycythemia vera or…. Sold as Inrebic. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Fedratinib Hydrochloride (sold as Inrebic), first approved Aug 16, 2019, with 0 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 16, 2019 | InrebicNDA 212327 · New molecular entity | Bristol-Myers | 7 | Marketed |
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
