Bayer announces FDA approval for its Gadavist injection

Recently, Bayer announced that the U.SFDA(http://has approved Gadavist injections for cardiac magnetic resonance imaging (CMRI) for the evaluation of myocardial perfusion and advanced radon enhancement (LGE) in adult patients with known or suspected coronary artery disease (CAD)Gadavist is the first and only FDA-approved magnetic resonance contrast agent for CMRI in CAD patientsThe approval was based on two forward-looking, open-label, non-random, multi-center, blind-read Phase III studies that enrolled nearly 800 patients and assessed Gadavist's ability to use CMRI to help detect known CAD or help identify suspected cases based on symptomsThe results confirmed the validity of GadavistGadavist is the American brand name of 1.0 mol concentration of meldonic solution, the European brand is called Gadovist, and the other regional brand is called Gadovist 1.0Gadavist, a Gd-based episoquial, was first approved for comparative enhanced magnetic resonance imaging for the central nervous system in 1998 and has been approved for multiple indications in more than 100 countries around the world, including the European Union, China, Japan, and the United StatesGadavist is the most clinically used MR contrast agent, with more than 50 million Gadavist/Gadovist enhanced MRI tests conducted worldwide to dateIn China, Gadavist was approved in April this year for AN MRI tests for children under 2 years of age, including full-term newbornsThe approval also makes Gadavist the first high concentration, high relaxation rate, large ring magnetic resonance contrast agent (GBCA) for children under 2 years of age with systemic indications