{"entity":{"id":"optison","kind":"drug","name":"Perflutren protein-type A microspheres (ultrasound contrast)","aka":["Optison","perflutren albumin microspheres"],"tldr":"Gas bubbles in a protein shell injected into a vein during a heart ultrasound to show the heart's pumping chamber more clearly.","summary":"GE Healthcare's Optison (NDA 020899, first approved 31 December 1997) is indicated \"for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders\", with the same boxed warning on serious cardiopulmonary reactions as other perflutren products. In the European Union it has been authorised since 17 May 1998 (EMEA/H/C/000166). ATC V08DA01.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA Optison (NDA 020899)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020899"},{"label":"DailyMed label: Optison","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=46bcf276-d423-408a-a410-f11383406a94"},{"label":"EMA: Optison","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/optison"},{"label":"WHO ATC index V08DA: ultrasound contrast media","url":"https://atcddd.fhi.no/atc_ddd_index/?code=V08DA&showdescription=no"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":[],"sections":[],"technologies":["ultrasound-contrast-agents","ultrasound","ultrasound-elastography-ceus"],"targets":[],"drugs":[],"companies":["ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo contrast agent gap fill (Drugs@FDA, FDA labels, DailyMed, EMA register, WHO ATC index)","editedOn":"2026-11-04"},"brand":"Optison","modality":"Ultrasound contrast agent, albumin-shelled gas microbubbles for echocardiography (intravenous)","mechanism":"Microbubbles of perflutren gas in a shell of human albumin reflect ultrasound and opacify the heart chambers.","approvals":[{"region":"US","year":1997,"indication":"Opacification of the left ventricle in patients with suboptimal echocardiograms","note":"NDA 020899; GE Healthcare"},{"region":"EU","year":1998,"indication":"Transpulmonary echocardiographic contrast","note":"Authorised 17 May 1998; GE Healthcare AS"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/optison/","neighbours":{"technology":[{"id":"ultrasound-elastography-ceus","kind":"technology","name":"Elastography and contrast-enhanced ultrasound","route":"/technologies/ultrasound-elastography-ceus/"},{"id":"ultrasound","kind":"technology","name":"Ultrasound","route":"/technologies/ultrasound/"},{"id":"ultrasound-contrast-agents","kind":"technology","name":"Ultrasound contrast agents (microbubbles)","route":"/technologies/ultrasound-contrast-agents/"}],"company":[{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"}]}}