Optison

For suboptimal echocardiograms. NDA 20899, held by Ge Healthcare. Albumin Human.

As of Nov 13, 2026, NDA 20899 (Optison), held by Ge Healthcare, was first approved by FDA on Dec 31, 1997, with 17 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1997
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OPTISON 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below


May 9, 2025	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 17, 2012	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 31, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Optison10MG/ML · injectable;injection	Albumin Human	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


May 9, 2025	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 16, 2021	Supplement 24Labeling · Standard review	Approved	Letter Label
Sep 1, 2021	Supplement 23Labeling · Standard review	Approved	Letter
Sep 16, 2016	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 16, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 15, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Nov 15, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 17, 2012	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 6, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 8, 2007	Supplement 10Labeling · Standard review	Approved	Letter
May 10, 2002	Supplement 7Manufacturing · Standard review	Approved	Label Letter
Dec 18, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 14, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Feb 4, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
May 6, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 1, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 31, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 31, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20899
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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