FDAnews Drug Daily Bulletin

INEX RECIEVES NOTICE OF 'NON-COMPLIANCE' FROM HEALTH CANADA ON CANCER DRUG

Nov. 28, 2005
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Inex Pharmaceuticals Corp. announced late Tuesday it has received a notice of "non-compliance" from the Therapeutics Products Directorate of Health Canada on its cancer treatment Marqibo. The company said the Health Canada's decision was consistent with the feedback from the U.S. Food and Drug Administration requiring data from randomized Phase 3 clinical trials be generated before Marqibo could be considered for marketing approval.

Canada.com (http://www.canada.com/health/story.html?id=a093c894-c5c8-45eb-80c7-562e750198f9)