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November 15, 2006
NYT: FDA Panel on Sanofi-Aventis Drug Ketek
Article in the New York Times -- F.D.A. to Seek Advice of Expert Panel on Safety of Sanofi-Aventis Drug, by Reuters:
Food and Drug Administration officials said Tuesday they planned to ask outside advisers next month if the antibiotic Ketek made by Sanofi-Aventis should stay on the market after reports of liver failure in a dozen patients.
The antibiotic which was approved in 2004 is also the subject of a Senate Finance Committee investigation of the F.D.A.’s handling of the approval and of possibly faulty data.
“We will ask the committee if the overall risk/benefit profile supports continued marketing of Ketek for various indications,” an F.D.A. spokeswoman, Laura Alvey, said.
Here's a link to the Wall Street Journal article, Review of Sanofi Drug is Sought, by the Associated Press.
BGS
November 15, 2006 in FDA | Permalink
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Comments
Prof Erichson --
Had you for Civil Procedure at Seton Hall a number of years back and saw you commenting on a lot of pharmaceutical litigation -- Ketek is a very interesting drug -- as is hormone therapy which I saw they also asked you for comment on... that mistrial there was wild.
Posted by: Brian | Dec 5, 2006 8:30:18 PM
Brian -- Nice to hear from you, and I hope all's well. I haven't followed Ketek, but the Prempro/HRT litigation is at a really interesting stage, and I agree with you that the mistrial in Philadelphia was a strange twist. In my Complex Litigation class this semester, we'd been discussing the implications of the early Prempro trials as they developed in both the MDL and state court, and I recall my students' surprise at the news of the mistrial in the Jennie Nelson case.
Posted by: Howard Erichson | Dec 6, 2006 8:30:53 AM
