For suboptimal echocardiograms. NDA 203684, held by Bracco. Sulfur Hexafluoride Lipid-Type A Microspheres.
As of Nov 14, 2026, NDA 203684 (Lumason), held by Bracco, was first approved by FDA on Oct 10, 2014, with 5 approved supplements and 0 published complete response letters.
Echocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.
| Nov 13, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Mar 31, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 10, 2014 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lumason60.7MG/25MG · for suspension;intravenous | Sulfur Hexafluoride Lipid-Type A Microspheres | RxReference drug |
| Apr 9, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Dec 2, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Nov 13, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2016 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Mar 31, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 10, 2014 | Original applicationNew molecular entity · Standard 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
