The approved supplemental new drug application was based on the results of the company’s successful phase III trial in 510 community-acquired pneumonia (CAP) patients comparing a five-day treatment and the originally approved seven-day treatment with Factive 320mg once-daily.
Oscient first launched the drug for the seven-day treatment of CAP and the five-day treatment of acute bacterial exacerbations of chronic bronchitis (AECB) in 2004.
Steven Rauscher, president and CEO of Oscient, said: “A key goal for Oscient has been to pursue short course therapy with Factive in all of our licensed territories and Factive is now the only fluoroquinolone approved in the US for the five-day treatment of both AECB and CAP.”