Dotarem

Used in scans for disruption of the blood brain barrier (BBB) and/or abnormal vascularity. NDA 204781, held by Guerbet. Gadoterate Meglumine.

As of Nov 14, 2026, NDA 204781 (Dotarem), held by Guerbet, was first approved by FDA on Mar 20, 2013, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 20, 2013
Review: Priority
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DOTAREM is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Aug 25, 2017	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Medical Review
Mar 20, 2013	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label Letter

Products

5 strengths and forms


Dotarem37.69GM/100ML (376.9MG/ML) · solution;intravenous	Gadoterate Meglumine	RxReference drug
Dotarem3.769GM/10ML (376.9MG/ML) · solution;intravenous	Gadoterate Meglumine	RxReference drug
Dotarem5.6535GM/15ML (376.9MG/ML) · solution;intravenous	Gadoterate Meglumine	RxReference drug
Dotarem7.538GM/20ML (376.9MG/ML) · solution;intravenous	Gadoterate Meglumine	RxReference drug
Dotarem1.8845GM/5ML (376.9MG/ML) · solution;intravenous	Gadoterate Meglumine	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Mar 5, 2025	Supplement 17Labeling · Standard review	Approved	Label Medication Guide Letter Letter
Aug 14, 2024	Supplement 14Labeling · Standard review	Approved	Label Letter
Jul 23, 2024	Supplement 16Labeling · Standard review	Approved	Label Letter
Jan 26, 2024	Supplement 15Labeling · Standard review	Approved	Label Letter
Jul 23, 2019	Supplement 12Labeling · Standard review	Approved	Label Letter
Nov 2, 2018	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 26, 2018	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 14, 2017	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 25, 2017	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Clinical Pharmacology Review Pediatric Medical Review
Mar 31, 2017	Supplement 2Manufacturing	Approved	None posted
Mar 20, 2013	Original applicationNew molecular entity · Priority review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 204781
Drugs@FDA: Overview at FDA
Company: Guerbet

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