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See Latest ArticlesCell Therapeutics Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkins Lymphoma
Cell Therapeutics, 10/07/09
Cell Therapeutics, Inc. announced that it has applied to the European Medicines Agency for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL. CTI anticipates the formal Marketing Authorization Application filing in 2010 following approval of the pediatric investigation plan which was submitted to the EMEA earlier this month. CTI would be granted 10 year market exclusivity in Europe if the MAA is approved.
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