ANDA 215957, held by Ge Hlthcare. Gadobutrol.
As of Nov 15, 2026, ANDA 215957 (Pixxoscan), held by Ge Hlthcare, was first approved by FDA on Jun 29, 2026, with 0 approved supplements and 0 published complete response letters.
Pixxoscan is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neonates MRI of the breast to assess the presence and extent of malignant breast disease in adult patients Magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients including term neonates Cardiac MRI (CMRI) to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD) Pixxoscan is a gadolinium-…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2026 | Original application | Approved | None posted |
| Pixxoscan1.20944GM/2ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Pixxoscan4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Pixxoscan6.0472GM/10ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Pixxoscan9.0708GM/15ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
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
