Elucirem

For magnetic resonance imaging (MRI). NDA 216986, held by Guerbet. Gadopiclenol.

As of Nov 14, 2026, NDA 216986 (Elucirem), held by Guerbet, was first approved by FDA on Sep 21, 2022, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2022
Review: Priority
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Vueway is indicated in adult and pediatric patients, including term neonates, for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine, and associated tissues) the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below


Feb 20, 2026	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Sep 21, 2022	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Letter Label

Products

7 strengths and forms


Elucirem1.4553GM/3ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem3.63825GM/7.5ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem4.851GM/10ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem7.2765GM/15ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem14.553GM/30ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem24.255GM/50ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug
Elucirem48.51GM/100ML (485.1MG/ML) · solution;intravenous	Gadopiclenol	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Feb 20, 2026	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label Medication Guide
Mar 5, 2025	Supplement 6Labeling · Standard review	Approved	Label Letter
Aug 14, 2024	Supplement 3Labeling · Standard review	Approved	Letter
Jul 23, 2024	Supplement 5Labeling · Standard review	Approved	Label Letter
Jan 26, 2024	Supplement 2Labeling · Standard review	Approved	Label Letter
Sep 21, 2022	Original applicationNew molecular entity, new combination · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 216986
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