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Pfizer Trovan

Executive Summary

Public Citizen's Health Research Group files a citizen petition June 3 requesting that FDA withdraw trovafloxacin from the market in response to 140 post-marketing reports of liver toxicity ("The Pink Sheet" May 31, p. 6). The HRG petition maintains that "the removal of Trovan from the market will not deprive doctors or patients," given that there are seven other fluoroquinolone antibiotic products available in the U.S. HRG asserts that there was evidence of liver damage caused by Trovan prior to FDA approval based on three preclinical studies. The group asserted that "this is yet another instance of a lower standard for approving drugs in recent years"

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