First Drug in New Class of Antibiotics Approved

December 31, 2006

The FDA has approved Ketek (telithromycin) fromAventis Pharmaceuticals to treat acute exacerbationof chronic bronchitis, acute bacterial sinusitis, and mild tomoderate community-acquired pneumonia. This is thefirst agent in a new class of antibiotics known as ketolides.Ketek has already been released in European, Latin American,and Asian markets.

The FDA has approved Ketek (telithromycin) fromAventis Pharmaceuticals to treat acute exacerbationof chronic bronchitis, acute bacterial sinusitis, and mild tomoderate community-acquired pneumonia. This is thefirst agent in a new class of antibiotics known as ketolides.Ketek has already been released in European, Latin American,and Asian markets.Ketek targets respiratory pathogens, including resistantstrains of Streptococcus pneumoniae, without appreciablyaffecting other bacteria in the body. Ketek is availableas a 400-mg tablet; it is approved for use in patients aged18 years and older. The most common side effects in clinicaltrials were nausea, headache, dizziness, vomiting, anddiarrhea.