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.

Short name: Ami 227, generic name: Ferumoxtran, (USPIO)
Ferumoxtran is a substance of the class of ultrasmall superparamagnetic iron oxide used as a lymph node specific contrast agent for MRI.
See also Combidex®, Sinerem® and Ultrasmall Superparamagnetic Iron Oxide.
Partner(s): Cytogen Corporation, National Cancer Institute. An approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. Advanced Magnetics, Inc. has submitted a complete response to the approvable letter received from the U.S. Food and Drug Administration, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005. In Europe, a Dossier (the European equivalent of a NDA) was submitted by Advanced Magnetics' European partner, Guerbet SA, to the European Medicines Evaluations Agency in December 1999. (Sinerem® is the brand name for this USPIO in Europe manufactured by Guerbet, Combidex® by Advanced Magnetics for the U.S. market)
Advanced Magnetics, Inc. changed its name in July 2007 to AMAG Pharmaceuticals Inc.

The company changed its name from Advanced Magnetics, Inc. to AMAG Pharmaceuticals, Inc. in July 2007.
AMAG Pharmaceuticals, Inc., a biopharmaceutical company, developed and manufactured organ-specific diagnostic contrast agents that provide clearer images during magnetic resonance imaging (MRI) tests used to detect tumors and other abnormalities.
The company had two MRI related products on the market: Feridex I.V. (for the diagnosis of liver lesions) and GastroMARK (used for bowel and abdominal MR imaging). In November 2008, AMAG Pharmaceuticals, Inc. decided to discontinue the manufacturing of Feridex. The development of Combidex as a contrast agent for lymph disease has also been stopped.
The Company has now two commercial products: Feraheme® and GastroMARK®. Feraheme® is the trade name of Ferumoxytol (formerly Code 7228) and is indicated for the treatment of iron deficiency anemia. Feraheme® is also being developed as a diagnostic agent for vascular-enhanced magnetic resonance imaging (MRI) to assess peripheral arterial disease.

MRI Contrast Agents:

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Cytogen Corporation of Princeton, NJ is a product-driven, oncology-focused biopharmaceutical company. Cytogen markets several products through its in- house oncology sales force: ProstaScint® (a monoclonal antibody-based imaging agent used to image the extent and spread of prostate cancer); BrachySeed™ I-125 and BrachySeed™ Pd-103 (two uniquely designed, next generation radioactive seed implants for the treatment of localized prostate cancer), and NMP22® BladderChek™ (a highly accurate and convenient antibody-based point-of-care staging test for bladder cancer detection). Cytogen has also developed Quadramet®, a skeletal targeting therapeutic radiopharmaceutical for the relief of bone pain in prostate and other types of cancer. Cytogen's pipeline comprises product candidates at various stages of clinical development, including fully human monoclonal antibodies and cancer vaccines based on PSMA (prostate specific membrane antigen) technology, which was exclusively licensed from Memorial Sloan-Kettering Cancer Center.
A license and marketing agreement with AMAG Pharmaceuticals Inc' (formerly Advanced Magnetics), to market the functional molecular imaging agent Combidex®, was terminated in 2007.

Sinerem® is the brand name (same as Combidex®) for an ultrasmall superparamagnetic iron oxide (USPIO) to detect metastatic disease in lymph nodes. Metastatic 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.
Lymph node imaging with Sinerem® is performed 24 to 36 hours after slow infusion. Normal lymph nodes turn black post contrast, namely on T2* weighted images. Metastatic lymph nodes remain unchanged in signal intensity.
Indication and Diseases: Cancer, Imaging for diagnosis, Lymphatic disorders.
See Ferumoxtran, and Classifications, Characteristics, etc.

Guerbet decided in 2007 to withdraw its Marketing Authorisation Application (MAA) for Sinerem.