FiercePharma

FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age

Expanded use of Gadavist is specific to detecting and visualizing areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in pediatric patients under the age ...
TCTMD

FDA approves Bayer's Gadavist® (gadobutrol) injection as first contrast agent for use with magnetic resonance angiography of supra-aortic arteries

WHIPPANY, N.J., 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 ...
Medscape

FDA Okays MRI Contrast Agent (Gadavist) in Infants

The US Food and Drug Administration (FDA) has approved the first gadolinium-based MRI contrast agent, gadobutrol (Gadavist, Bayer Healthcare), for patients under 2 years of age. The injected agent is ...
FiercePharma

Bayer's gadavist injection gets FDA approval as MRI contrast agent

Bayer HealthCare has received approval from the US Food and Drug Administration (FDA) for a new indication for Gadavist (gadobutrol) injection for intravenous use with MRI of the breast to assess the ...
Medscape

FDA Approves New Contrast Agent for CNS Scans

March 16, 2011 — The US Food and Drug Administration (FDA) has approved gadobutrol (Gadavist, Bayer Pharmaceuticals), a gadolinium-based contrast agent, for use in patients undergoing magnetic ...
Medindia

U.S. FDA Approves Bayer's Gadavist(TM) (Gadobutrol) Injection for MRI of the Central Nervous System

WAYNE, N.J., March 14, 2011 Bayer HealthCare Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration has approved Gadavist(TM) (gadobutrol) Injection, a macrocyclic ...
pharmaphorum

FDA clears Bayer’s Gadavist as first contrast agent for cardiac MRI

Bayer’s Gadavist has become the first imaging agent approved in the US to detect blockages in the hearts of patients with known or suspected coronary artery disease (CAD). The magnetic resonance ...
TCTMD

FDA approves Bayer's Gadavist® (gadobutrol) injection as the first and only contrast agent for use in cardiac MR in adult patients with known or suspected coronary artery disease

WHIPPANY, N.J. - Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial ...
Monthly Prescribing Reference

Gadavist Approved for MRI of the CNS

Bayer HealthCare announced that Gadavist (gadobutrol injection), a macrocyclic gadolinium-based contrast agent, has been approved for intravenous use in diagnostic magnetic resonance imaging (MRI) in ...
Monthly Prescribing Reference

Gadavist Contrast Agent Gains Expanded Indication

Gadavist Contrast Agent Gains Expanded Indication Bayer HealthCare announced that he FDA has approved a new indication for Gadavist (gadobutrol) injection for IV use with MRI of the breast to assess ...
Renal & Urology News

Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing

Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers. The Food and Drug Administration (FDA) has approved the Gadavist® (gadobutrol; Bayer ...
Medindia

FDA approves Bayer''s Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States

- Gadavist-enhanced breast MRI demonstrated superior sensitivity (range: 80-89%) for the presence and extent of malignant disease compared to unenhanced breast MRI (range: 37-73%) "The Phase 3 GEMMA ...