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Paxil CR Vs. IR: GI Tolerability Claim Would Require Comparative Trials - FDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A claim of superior GI tolerability for GlaxoSmithKline’s Paxil CR over immediate release Paxil would need to be supported by "carefully conducted studies that would compare the CR and IR forms at equieffective points on the dose response curves," FDA Psychiatric Drug Products Team Leader Thomas Laughren, MD, said in review documents for Paxil CR’s panic disorder indication.

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