Combidex® is the brand name (same as Sinerem®) for an ultrasmall superparamagnetic iron oxide (USPIO) in the development pipeline to detect metastatic disease in lymph nodes. Metastatic lymph nodes show less uptake of this MRI contrast agent, which results in less signal decrease and allows the differentiation of normal lymph nodes from normal-sized, metastatic nodes. Combidex® has also potential to be used as a functional molecular imaging agent.
In March 2005, AMAG Pharmaceuticals Inc received an approvable letter from the U.S. Food and Drug Administration with respect to Combidex subject to certain conditions.
See also Ferumoxtran, Drug Development and Approval Process USA, Molecular Imaging and Classifications, Characteristics, etc.

Different stages of the drug development and approval process in the USA, lead from preclinical trials (testing in animals), first application in humans through limited and broad clinical tests, to postmarketing studies.

By Dale E. Wierenga, Ph.D. and C. Robert Eaton
Office of Research and Development
Pharmaceutical Manufacturers Association

'In reviewing this report, it is important to keep in mind the realities of the drug discovery and development process. The U.S. system of new drug approvals is perhaps the most rigorous in the world. On average, it costs a company $359 million to get one new medicine from the laboratory to the pharmacist's shelf, according to a February 1993 report by the Congressional Office of Technology Assessment.'

See also Phase 1 2 3 4 Drug Trials, Food and Drug Administration, and European Medicines Agency.

Short name: Mn-DPDP
This MRI contrast agent is a chelate complex of the paramagnetic metal ion manganese (Mn) and fodipir. Mn-DPDP (Teslascan) shortens the longitudinal relaxation time and is used for the T1 weighted enhancement of MR images. Mangafodipir trisodium accumulates after intravenous injection in the healthy tissue of the liver and improves the detection, localization, characterization, and evaluation of lesions of the liver, pancreas, but can also be used in cardiac MRI.
See also Hepatobiliary Chelates and Teslascan®.
The United States Food and Drug Administration (FDA) has granted marketing clearance 1997, to Nycomed Amersham's MRI contrast medium. Nycomed/Amersham, now GE Healthcare markets the product under the trade name Teslascan®.

Vasovistâ„¢ is an albumin-targeted intravascular contrast agent. It is indicated for contrast enhanced MR angiography (CE-MRA) for the visualization of abdominal or limb vessels in patients with suspected or known vascular disease. After IV injection, Vasovistâ„¢ binds reversibly to human albumin in plasma, which results in long-lasting increased relaxivity. Imaging from 5 to 50 min is possible. A small unbound portion is, by glomerular filtration, eliminated by the kidneys.
AngioMARK® was the formerly trade name and MS-325 the research name. Currently the phase III clinical trials are completed to determine its efficacy for peripheral vascular disease and coronary artery disease.
In the U.S., EPIX received an approvable letter from the U.S. Food and Drug Administration (FDA) for Vasovistâ„¢ in January 2005. In 2009, Epix Pharmaceuticals has sold the U.S., Canadian and Australian rights for its blood pool agent (now named ABLAVARâ„¢), to Lantheus Medical Imaging, Inc..

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or chronic severe renal insufficiency (glomerular filtration rate less than 30 mL/min/1.73m²), or acute renal insufficiency of any severity due to the hepato-renal syndrome or the liver transplantation period.

See also MRI Safety.