Sanofi Antibiotic Ketek Said Safe By The FDA
As regular readers know, I’ve been following the issues surrounding Ketek (telithromycin) an antibiotic from Sanofi-aventis and reports that it has caused some liver problems.
UPDATE 3-Studies support Sanofi antibiotic, say FDA staff | Reuters.com:
The FDA has had meetings Dec 14-15 on this product as a joint meeting involving both the anti-infective drug advisory committee and the drug safety and risk management advisory committee. It will be interesting to see what comes out of this meeting. We may know later today but most likely early next week.
If you want to know the background as well as key dates in the approval history of Ketek then I recommend the Brief documetn listed below which has a lot of good background material on the product.
Once transcripts are available, i’ll post links to them.
Other Resources
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling (press release of June 29, 2006)
Advisory Committees: CDER 2006 Meeting Documents
BRIEFING DOCUMENT AVAILABLE FOR PUBLIC DISCLOSURE: KETEK® (telithromycin)
Technorati Tags: drug safety, FDA, Ketek, Sanofi, Sanofi-Aventis, telithromycin
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