Saturday, December 16, 2006
Article in the New York Times -- Drug Maker Takes Issue With F.D.A. Panel, from Reuters:
Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek.
Ketek is used in the treatment of acute bacterial worsening of bronchitis or acute bacterial sinusitis.
The F.D.A. advisory panel earlier supported continued sales of Ketek for treating pneumonia acquired outside a hospital.
For additional coverage, see the Wall Street Journal article, Sanofi Antibiotic Takes Hit From FDA Advisers, by Anna Wilde Matthews.