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Noxafil NDA Gets Priority Review

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Schering-Plough’s NDA for Noxafil Oral Suspension (for use in preventing serious invasive fungal infections (IFIs) in high-risk patients) has been granted a six-month priority review by the FDA. Priority review designation is granted to drugs that, if approved, would be a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease. The company is seeking U.S. marketing approval of Noxafil for prophylaxis of serious invasive fungal infec...

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