The US Food and Drug Administration said that it will not approve Replidyne and Forest Laboratories' antibiotic faropenem medoxomil unless further studies are carried out on this new antibiotic. Replidyne submitted a new drug application in December 2005 for four indications including acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis, and uncomplicated skin and skin structure infections. The FDA has said that it requires trials for all four indications. The companies said that they believed recent public FDA deliberations over the need for placebo controlled studies for antibiotics were a factor in its decision. (FDA)
