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Menarini submits regulatory filing for Factive in Europe

Oscient Pharmaceuticals's commercialization partner for Factive tablets, Menarini Group, has submitted a regulatory filing seeking approval of Factive in Europe.

Menarini is seeking approval of Factive for the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. The regulatory review time in Europe is approximately 12 months.

Steven Rauscher, president and CEO of Oscient, said: “Menarini’s pursuit of marketing approval for Factive in Europe is an important step in our commercialization plan for Factive in our licensed territories. Menarini is a strong, experienced partner, and we look forward to working together to build the Factive brand in Europe.”