For New York Heart Association (NYHA) class II or class III heart failure and left…. Sold as Adreview. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Iobenguane Sulfate I-123 (sold as Adreview), first approved Sep 19, 2008, with 1 new use approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular · Children's Oncology Group | Phase 3 | Recruiting | Apr 25, 2017 |
| Sep 19, 2008 | AdreviewNDA 22290 · New molecular entity | Ge Healthcare | 3 | Marketed |
| Dec 9, 2024 | Iobenguane I-123ANDA 213637 | Bwxt Medcl | 0 | Discontinued |
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
Ge Healthcare