Oscient gets FDA OK for pneumonia drug

Massachusetts, USA-based Oscient Pharmaceuticals says that the Food and Drug Administration has accepted the firm's submission of a supplemental New Drug Application seeking marketing approval for the use of Factive (gemifloxacin mesylate) for the treatment of mild-to-moderate community-acquired pneumonia. The firm adds that a second Factive sNDA for the drug as a medication for acute bacterial sinusitis was rejected by the agency because it had not demonstrated a suitable risk versus benefit profile.

The FDA has granted the firm the standard 10 month review period for the five-day CAP indication of the drug and said that it would act on the filing by the end of September this year.

The drug, which is already approved as a treatment for acute bacterial exacerbations of chronic bronchitis, and as a seven-day regimen for CAP, has demonstrated efficacy in Phase III clinical trials as a treatment for pneumonia (Marketletter June 13, 2005).