Treats endogenous hypercortisolemia. Sold as Recorlev. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Levoketoconazole (sold as Recorlev), first approved Dec 30, 2021, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Recorlev | Part D | $79.6M | +169% | 494 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 30, 2021 | RecorlevNDA 214133 ยท New active ingredient | Strongbridge | 1 | 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
