Lilly Strattera "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
FDA's Aug. 12 "approvable" letter for Strattera (atomoxetine) requests data that will require "analyses from either existing studies or a potential new study" of the non-stimulant attention deficit hyperactivity disorder product, Lilly says. The firm "continues to plan for final FDA approval in the spring of 2003," although "approval timing is contingent upon further discussions with the FDA regarding the additional data requested
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