FDA asks for more data on Genasense
The US Food and Drug Administration has decided that available data are not adequate to support the approval of Genta's Genasense (oblimersen sodium) injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia.
In a decision issued in response to an appeal by Genta in December 2008, the FDA concluded that information submitted by the company in its amended New Drug Application was insufficient, and the agency has recommended conducting a confirmatory trial.
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