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ChemGenex Pharmaceuticals Limited (CXS.AX) Receives a Complete Response Letter from the FDA for OMAPRO(TM)


4/12/2010 9:30:44 AM

MELBOURNE, Australia & MENLO PARK, Calif.--(BUSINESS WIRE)--ChemGenex Pharmaceuticals announces that the U.S. Food and Drug Administration’s (FDA) Office of Oncology Drug Products has issued a complete response letter regarding the new drug application (NDA) for OMAPRO™ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and have the Bcr-Abl T315I mutation.

Read at BioSpace.com

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