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Article: Cell Therapeutics Applies for European Orphan Drug Designation for Pixantrone in Aggressive Non-Hodgkin's Lymphoma (NHL).
- Article from:
- PR Newswire
- Article date:
- September 29, 2009
CopyrightCOPYRIGHT 2009 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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SEATTLE, Sept. 29 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) announced today that it has applied to the European Medicines Agency (EMEA) 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 (MAA) 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. In the United States, the pixantrone New ...