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Public Citizen Sues FDA To Force Withdrawal Of Bristol's Serzone

This article was originally published in The Pink Sheet Daily

Executive Summary

The lawsuit follows a March 2003 petition asking for nefazodone to be pulled. The advocacy group argues that the antidepressant offers no benefit over other drugs and presents unpredictable liver risks.

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Bristol Serzone Hepatic Risk Suggests Need For Second-Line Use, Revised Labeling Says

Approval of revised nefazodone labeling roughly coincides with the timing of Bristol's decision to remove Serzone from the market for commercial reasons. Impact of labeling revision will therefore fall on marketers of generic nefazodone.

Bristol Serzone Hepatic Risk Suggests Need For Second-Line Use, Revised Labeling Says

Approval of revised nefazodone labeling roughly coincides with the timing of Bristol's decision to remove Serzone from the market for commercial reasons. Impact of labeling revision will therefore fall on marketers of generic nefazodone.

Bristol Pulls Serzone; Cites Generic Erosion, Not Safety Issues

In a letter to wholesalers, Bristol said the antidepressant will no longer be shipped after June 14. Public Citizen called the withdrawal inadequate since the company is not ordering a recall and nefazodone generics are still available.

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