OSCIENT SUBMITS SNDA FOR FACTIVE TABLETS

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Oscient Pharmaceuticals has submitted a supplemental new drug application to the FDA seeking approval for the use of Factive (gemifloxacin mesylate) tablets for the five-day treatment of acute bacterial sinusitis (ABS) and the five-day treatment of mild-to-moderate community-acquired pneumonia (CAP). 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.

The sNDA for the five-day treatment of ABS contains efficacy and safety data from five Phase III trials involving more than 1,800 patients receiving Factive and 500 patients receiving a comparator (trovafloxacin or cefuroxime). The filing is also supplemented by safety data gathered from the postmarketing surveillance of Factive since its launch in September 2004.