For magnetic resonance imaging (MRI). NDA 219627, held by Bayer Healthcare. Gadoquatrane.
As of Nov 13, 2026, NDA 219627 (Ambelvist), held by Bayer Healthcare, was first approved by FDA on Jun 12, 2026, with 0 approved supplements and 0 published complete response letters.
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)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2026 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ambelvist0.5158GM/2ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
| Ambelvist1.93425GM/7.5ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
| Ambelvist2.579GM/10ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
| Ambelvist3.8685GM/15ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
| Ambelvist7.737GM/30ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
| Ambelvist16.7635GM/65ML (257.9MG/ML) · solution;intravenous | Gadoquatrane | RxReference drug |
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
