Food & Drug Law Weekly
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ILEX Oncology Inc.
New patient data to support clofarabine NDA for pediatric leukemia
September 24th, 2004
ILEX Oncology Inc. (ILXO) has chosen to provide the U.S. Food and Drug Administration (FDA) with new patient data to support the New Drug Application (NDA) it submitted for clofarabine for the treatment of refractory or relapsed acute leukemia in children. The decision to update the filing was based on encouraging efficacy results from a cohort of additional patients. Based on the significant new data added to the original filing, the FDA has reset the Prescription Drug User Fee Act (PDUFA) response date to December 30, 2004. "ILEX chose to submit these results so the FDA could assess a larger body of data," said ILEX Chief Medical Officer and...
Source: Food & Drug Law Weekly (2004-09-24)
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