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FDA to Review Tablet Formulation of Antifungal Drug Posaconazole (Noxafil)
Approval sought for once-daily administration (Apr. 10)
The FDA has accepted a new drug application (NDA) for an investigational tablet formulation of the antifungal agent posaconazole (Noxafil, Merck).
Posaconazole is currently marketed as Noxafil Oral Suspension for prophylaxis of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as patients who have received hematopoietic stem-cell transplants and have graft-versus-host disease, or patients with cancers of the blood who are experiencing prolonged neutropenia as a result of chemotherapy.
Regulatory approval is being sought for once-daily administration of the posaconazole tablets (following a twice-a-day loading dose on the first day of therapy).
The safety and efficacy of posaconazole have not been established in patients younger than 13 years of age.
Source: Merck; April 10, 2013.