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Geodon oral suspension "not approvable"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA issues "not approvable" letter for Pfizer's oral suspension formulation of the antipsychotic Geodon (ziprasidone) in July. "Responses to the FDA's questions will be submitted as soon as possible," Pfizer says in its second quarter report. The company plans to pursue an acute bipolar mania indication for Geodon with a filing, based on a recently completed clinical trial, slated for later this year..
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