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

Published: Apr 12, 2010

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.

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