Treats symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity…. Sold as Turalio. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Pexidartinib Hydrochloride (sold as Turalio), first approved Aug 2, 2019, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Turalio | Part D | $3.9M | +63% | 31 |
| Program | Updated |
|---|---|
| Turalio REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled · Letters to doctors | Aug 27, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 2, 2019 | TuralioNDA 211810 · New molecular entity | Daiichi Sankyo Inc | 14 | 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
