As expected, the FDA has formally rejected Johnson & Johnson's Zarnestra for acute myeloid leukemia. Given the FDA advisory council's decision last month that one Phase II trial provided insufficient evidence to back the application, that ruling had been factored in by most analysts. J&J was looking for an FDA approval to use the drug on seniors who were not good candidates for chemotherapy. J&J said it isn't discouraged by the rejection, though. The company says it is "committed" to Zarnestra and is studying the FDA's response to determine what its next step will be.
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