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6:08 PM
Oct 26, 2012
 |  BC Extra  |  Top Story

FDA approves Teva's Synribo

FDA granted accelerated approval to an NDA from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) for Synribo omacetaxine mepesuccinate to treat chronic or accelerated phase chronic myelogenous leukemia (CML) in patients who have resistance and/or intolerance to two or more tyrosine kinase inhibitors. Teva said it will launch Synribo in the next three weeks. FDA based the approval on pooled response rate data from two open-label Phase II trials....

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