Historical Information on Telithromycin (marketed as Ketek)

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FDA/Center for Drug Evaluation and Research

This is historical information only.
For current information, click on telithromycin (marketed as Ketek), click on http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm

Patient Information Sheet (7/21/2006) The information in this sheet has been updated and is addressed in product labeling including a Medication Guide for patients.
Public Health Advisory (1/20/2006, corrected 2/16/2007)
FDA News: FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling (6/29/2006, corrected 4/11/2007)
Questions and Answers (7/5/2006, corrected 4/11/2007)
Questions and Answers (1/20/2006, updated 5/18/2006, corrected 4/10/2007)
Regulatory History and Labeling Information for Ketek from Drugs@FDA

Date created: July 5, 2006; updated April 12, 2007