Wednesday, November 15, 2006
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.