However, the US regulator has refused to accept a similar filing for the drug in the five-day treatment of acute bacterial sinusitis (ABS).
The FDA is expected to begin its 10-month review of the five-day community-acquired pneumonia (CAP) filing by the end of September 2006.
Factive is currently approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and the seven-day treatment of mild to moderate CAP.
In its refusal to accept the filing for ABS, the regulator indicated that Factive did not exhibit an acceptable risk versus benefit profile for the ABS indication, and also that it believes it will not be feasible to demonstrate such a profile for the drug.
Steven Rauscher, president and CEO of Oscient, said that the company was pleased the drug has been accepted for review in the CAP indication, but also expressed disappointment over the decision not to allow an ABS indication.
“We have worked diligently with the FDA to compile an application that included supplemental clinical data and post-marketing safety reports, as well as a commitment to conduct additional post-approval surveillance, in order to assemble a submission that we believed would support approval of Factive for ABS,” stated Mr Rauscher.