This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary"Approvable" action is expected in September for the antipsychotic ziprasidone, Pfizer Global R&D President John Niblack reports in a July 26 conference call. "From there…things can go fast or they can go slow, depending on how well we agree with [the labeling] they give us," he said. FDA's Psychopharmacological Drugs Advisory Committee recommended approval of the agent for first-line use July 19, despite concerns about QTc prolongation that led FDA's Cardio-Renal Drugs Division to recommend non-approval or a second-line indication. The committee suggested that labeling clearly warn against combination use with other drugs that prolong QTc interval but said that a black box warning may not be necessar
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