Oscient gets FDA approvable letter for Factive five-day pneumonia tablets

By Elaine Rigoli

Tampa, Fla., Sept. 22 - Oscient Pharmaceuticals Corp. said it received an approvable letter from the Food and Drug Administration for the supplemental New Drug Application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity with Factive (gemifloxacin mesylate) tablets.

Factive is approved for the five-day treatment of acute bacterial exacerbations of chronic bronchitis and the seven-day treatment of community-acquired pneumonia.

According to the letter, the Waltham, Mass.-based biopharmaceutical company is required to provide clarification and additional interpretation regarding certain data included in the application to assist the FDA in its evaluation.

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