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 equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is Advanced Magnetics’ third product.

The company’s 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.