Eovist

Used in scans for known or suspected focal liver disease. NDA 22090, held by Bayer Hlthcare. Gadoxetate Disodium.

As of Nov 14, 2026, NDA 22090 (Eovist), held by Bayer Hlthcare, was first approved by FDA on Jul 3, 2008, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 3, 2008
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Mar 27, 2015	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 3, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

2 strengths and forms


Eovist1.8143GM/10ML (181.43MG/ML) · solution;intravenous	Gadoxetate Disodium	RxReference drug
Eovist2.72145GM/15ML (181.43MG/ML) · solution;intravenous	Gadoxetate Disodium	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Feb 13, 2026	Supplement 25Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 5, 2025	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 14, 2024	Supplement 23Labeling · Standard review	Approved	Letter
Jul 23, 2024	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 30, 2024	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 28, 2021	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 1, 2021	Supplement 19Labeling · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Jul 26, 2018	Supplement 15Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 26, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 27, 2015	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 16, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 16, 2013	Supplement 8Labeling · Standard review	Approved	Letter Label
Feb 4, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 16, 2011	Supplement 5Labeling	Approved	Letter Label
Dec 20, 2010	Supplement 4Labeling	Approved	Letter Label
Nov 13, 2009	Supplement 2Manufacturing · Standard review	Approved	Letter
Jul 3, 2008	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22090
Drugs@FDA: Overview at FDA
Company: Bayer 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