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Aventis Ketek Will Return To FDA Advisory Committee Jan. 8

Executive Summary

FDA's Anti-Infective Drugs Advisory Committee will review the safety profile of Aventis' Ketek (telithromycin) on Jan. 8, Exec VP-Commercial Operations Thierry Soursac told an investor conference call Oct. 29

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Aventis submits additional Ketek information

Aventis submits additional analysis of clinical studies and postmarketing surveillance data in response to FDA's Jan. 24 "approvable" letter for antibiotic Ketek (telithromycin). The company filed additional safety data in 2002 following a June 2001 "approvable" letter (1"The Pink Sheet" Nov. 4, 2002, p. 16)...

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