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Chart: Campral Clinical Development

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Campral Clinical DevelopmentDateActionIND Chronology (#51-809)6/25/1996Pre-IND meeting; FDA agrees to clinical program based on single pivotal U.S. study of 500 mg formulation with two European studies of original 333 mg formulation as supporting evidence10/29/1996IND submission10/27/1998End-of-Phase II meeting1/27/2000Pre-NDA meeting; FDA/Lipha discuss failure of U.S. trial; agency rejects Lipha's proposal to use post hoc analysis of European studies as support, requests new U.S. studyNDA Chronology (#21-431)12/27/2001NDA submission5/10/2002Psychopharmacologic Drugs Advisory Committee votes 8-2 that Campral showed efficacy in European studies5/24/2002FDA informs Lipha of plans not to approve NDA on first cycle6/27/2002Priority review user fee date; "not approvable" letter requests additional clinical study and safety audit10/9/2002Not approvable post-action meeting3/4/2003Not approvable post-action meeting; FDA agrees to re-audit of European study data instead of additional U.S. study12/19/2003Partial response to not approvable letter; FDA identifies deficiencies in response, including lack of information on pivotal trial audit and potential suicides2/4/2004Complete response to not approvable letter6/15/2004Pre-approval safety conference7/29/2004Approval8/4/2004Revised user fee dat
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