Published in Cancer Weekly, October 19th, 2004
The company previously filed a New Drug Application with the FDA for approval of clofarabine for the treatment of refractory or relapsed acute leukemia in children. The Prescription Drug User Fee Act (PDUFA) response date for this application is December 30, 2004.
"We look forward to the ODAC hearing," said ILEX Chief Medical Officer Steve Weitman, MD.
"This review is particularly important because in addition to the regulatory achievement this...
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