Therapy
Cell Therapeutics Initiates Process to Obtain Marketing Approval for Pixantrone in Europe
Published in Drug Law Weekly, August 11th, 2009
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that it was notified by the European Medicines Agency ("EMEA") that pixantrone is eligible to be submitted for a Marketing Authorization Application ("MAA") through the EMEA's centralized procedure. The centralized review process provides for a single coordinated review for approval of pharmaceutical products that is conducted by the EMEA on behalf of all European Union ("EU") member states. The EMEA also designated pixantrone as a New Active Substance ("NAS"); if approved, compounds designated as an NAS receive a 10-year market exclusivity period in EU member states. CTI will request a meeting with the EMEA to discuss the...
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Source: Drug Law Weekly (2009-08-11)
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