For New York Heart Association (NYHA) class II or class III heart failure and left…. NDA 22290, held by Ge Healthcare. Iobenguane Sulfate I-123.
As of Nov 13, 2026, NDA 22290 (Adreview), held by Ge Healthcare, was first approved by FDA on Sep 19, 2008, with 3 approved supplements and 0 published complete response letters.
AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.
| Mar 20, 2013 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2008 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adreview10mCi/5ML (2mCi/ML) · solution;intravenous | Iobenguane Sulfate I-123 | RxReference drug |
| Mar 5, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Jun 6, 2016 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Mar 20, 2013 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2008 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
