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Advanced Magnetics submits NDA for Combidex
Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The company’s European marketing partner, Guerbet, has also submitted the European
Contrast agent supplier Advanced Magnetics has submitted a new drug application (NDA) to the Food and Drug Administration for Combidex, an MRI contrast agent. The companys European marketing partner, Guerbet, has also submitted the European equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is Advanced Magnetics third product.
The companys U.S. NDA covers two indications: the diagnosis of lymph node disease and the detection, diagnosis, and evaluation of benign and malignant lesions of the liver and spleen. Advanced Magnetics hopes to receive priority review from the FDA for its Dec. 21 application, which would precipitate an action letter from the FDA six months from the application date rather than 12. Guerbet expects to launch Combidex in Europe in early 2001 under the trade name Sinerem.
The company hopes Combidex will help oncologists and radiologists to noninvasively stage metastatic cancer in lymph nodes. Advanced Magnetics plans to find a marketing partner for the agent, according to the Cambridge, MA-based firm.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
Study Reveals Benefits of Photon-Counting CT for Assessing Acute Pulmonary Embolism
April 23rd 2024In comparison to energy-integrating detector CT for the workup of suspected acute pulmonary embolism, the use of photon-counting detector CT reduced radiation dosing by 48 percent, according to newly published research.
