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See Latest ArticlesGenzyme Receives FDA Complete Response Letter for Clolar
Genzyme, 10/07/09
Genzyme Corporation announced that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar in previously untreated older adult patients with acute myeloid leukemia and at least one unfavorable baseline prognostic factor. The agency recommended a randomized, controlled clinical study be conducted for label expansion of Clolar in this indication.
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