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FDA Medication Tracker

← All approvals · Diagnostic & imaging agents · 2026

Ambelvist (gadoquatrane)

The FDA approved Ambelvist (gadoquatrane) on June 12, 2026 to detect and visualize lesions with abnormal vascularity, in conjunction with MRI.
Brand name
Ambelvist
Generic name
gadoquatrane
FDA approval date
June 12, 2026
Approved use (FDA wording)
To detect and visualize lesions with abnormal vascularity, in conjunction with MRI
Company
Bayer Healthcare
Application
NDA219627
Dosage form / route
SOLUTION · INTRAVENOUS
Boxed warning on label
Yes (see the FDA label)
Category on this site
Diagnostic & imaging agents

Indications and usage, from the FDA label

AMBELVIST 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) AMBELVIST is a gadolinium-based contrast agent 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) …

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.