Vanda’s Fanapt Approval Shows Evolution Of FDA’s Thinking
Executive Summary
FDA's approval of Vanda's Fanapt (iloperidone) May 6 means that the bar for new atypical antipsychotic approvals may not be as high as it seemed 10 months ago, when FDA's "not approvable" letter on iloperidone requested an additional comparative trial
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FDA's U-Turn On Fanapt: Comparative Assessments Must Have Clinical Meaning
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