CHALFONT ST GILES, England--(BUSINESS WIRE)--GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA). Pixxoscan has been reviewed using a regulatory decentralized procedure (DCP) with marketing authorization already in place in Austria and pending approval, will be introduced to a number of European countries in 2023.
Strides's Generic Gadobutrol Receives Approval in the U.S.
WHIPPANY, N.J.--(BUSINESS WIRE)--The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for Gadavist® (gadobutrol) in their September 29, 2020 issue. The publication includes data that supported the FDA approval of Gadavist to assess myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) in adult patients with known or suspected coronary artery disease (CAD).
The first and only FDA-approved gadolinium-based contrast agent for multi-patient dosing with an FDA-cleared Transfer Spike in the MR suite.
The FDA approved Bayer’s Gadavist MRI contrast agent to help gauge the blood supply of the heart muscle.
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use with magnetic resonance angiography (MRA) to evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates).1 The FDA approval is based on the results of two, multi-center, Phase 3, open-label clinical studies – the GEMSAV study of patients with known, or suspected vascular disease, of the supra-aortic arteries and the GRAMS study of patients with known or suspected renal artery disease.1
Bayer’s Gadovist (Gadobutrol) Approved in Japan For Magnetic Resonance Imaging