Merck's NDA for New Antifungal Formulation Accepted for Review
Merck announced that the FDA has accepted for review its New Drug Application (NDA) for an investigational tablet formulation of the company's antifungal agent, Noxafil (posaconazole). Merck is seeking FDA approval of Noxafil tablets for once-daily administration, following a twice daily loading dose on the first day of therapy.
Currently Merck markets 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. This is characterized by 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.
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