Drug Development

U.S. FDA grants NDA for 6-month priority review of treatment for invasive fungal infection

Published in Medical Letter on the CDC and FDA, March 26th, 2006

Schering-Plough Corporation (SGP) reported that the U.S. Food and Drug Administration (FDA) has granted a 6-month priority review to its New Drug Application (NDA) for Noxafil (posaconazole) Oral Suspension for use in preventing serious invasive fungal infections (IFIs) in high-risk patients.

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.

Schering-Plough is seeking U.S. marketing approval of Noxafil for prophylaxis of serious invasive fungal infections, including both moulds and yeasts, in patients who are at...

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Source: Medical Letter on the CDC and FDA (2006-03-26)

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