Bracco nets expanded labeling for MR agent
The FDA has approved the use of Bracco Diagnostics' MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in MR angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
MultiHance is a gadolinium-based contrast agent approved for intravenous use in MR imaging of the central nervous system (CNS) in adults and pediatric patients. The recommended dose for both MRI of the CNS and MRA exams is 0.1 mmol/kg (0.2 mL/kg) of MultiHance.
The approval of MultiHance in MRA was granted based on data submitted to the FDA that included safety and efficacy results from two large, prospective, multicenter clinical trials (one for each arterial vascular territory: renal and aorto-ilio-femoral), according to the Princeton, N.J.-based company.
MultiHance is a gadolinium-based contrast agent approved for intravenous use in MR imaging of the central nervous system (CNS) in adults and pediatric patients. The recommended dose for both MRI of the CNS and MRA exams is 0.1 mmol/kg (0.2 mL/kg) of MultiHance.
The approval of MultiHance in MRA was granted based on data submitted to the FDA that included safety and efficacy results from two large, prospective, multicenter clinical trials (one for each arterial vascular territory: renal and aorto-ilio-femoral), according to the Princeton, N.J.-based company.