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Posaconazole Granted Six-Month Priority Review by FDA

KENILWORTH, N.J., Feb. 22 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE:SGP) today 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(R) (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 high risk of developing these infections, such as hematopoietic stem cell transplant (HSCT) recipients or those with prolonged neutropenia.

Additionally, the NDA also seeks marketing approval of NOXAFIL for the treatment of oropharyngeal candidiasis (OPC), including refractory infections. This indication will receive a 10-month review by FDA. OPC is a fungal infection of the mouth and throat caused by the yeast Candida and is often referred to informally as thrush.

The company has filed a similar new drug application for NOXAFIL with the European Medicines Agency (EMEA). The product is currently approved in the European Union (EU) for the treatment of certain invasive fungal infections (IFIs) in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents.

NOXAFIL is a broad-spectrum triazole antifungal agent discovered and developed by Schering-Plough Research Institute that exhibits potent activity in vitro against a wide range of fungal pathogens, including both moulds and yeasts.

Invasive fungal infections, which can be life threatening, most often occur in people who are immunocompromised or immunosuppressed, such as cancer patients undergoing chemotherapy or stem cell transplants.

Source: Schering-Plough Corporation

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