ANDA 219287, held by Viwit Pharm. Gadobutrol.
As of Nov 15, 2026, ANDA 219287 (Gadobutrol), held by Viwit Pharm, was first approved by FDA on Jun 11, 2026, with 0 approved supplements and 0 published complete response letters.
Gadobutrol Injection 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) Gadobutrol Inje…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 11, 2026 | Original application | Approved | None posted |
| Gadobutrol4.5354GM/7.5ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol6.0472GM/10ML (604.72MG/ML) · solution;intravenous | Gadobutrol | Rx |
| Gadobutrol9.0708GM/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
