NDA 214375, held by Polarean. Xenon Xe-129 Hyperpolarized.
As of Nov 14, 2026, NDA 214375 (Xenoview), held by Polarean, was first approved by FDA on Dec 23, 2022, with 1 approved supplement and 1 published complete response letter.
XENOVIEW, prepared from the Xenon Xe 129 Gas Blend, is indicated for use with magnetic resonance imaging (MRI) for evaluation of lung ventilation in adults and pediatric patients aged 6 years and older. Limitations of Use XENOVIEW has not been evaluated for use with lung perfusion imaging.
| May 30, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 2022 | Original applicationNew molecular entity · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 5, 2021 | Xenoview (xenon-129 hyperpolarized)Product Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XenoviewN/A · gas;inhalation | Xenon Xe-129 Hyperpolarized | RxReference drug |
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
