FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release Tablets

Merck, known as MSD outside the US and Canada, has announced that FDA has approved NOXAFIL(posaconazole) 100 mg delayed-release tablets. NOXAFIL delayed-release tablets are a new formulation with a loading dose of 300 mg (three 100 mg delayed-release tablets) twice daily on the first day, followed by a once-daily maintenance dose of 300 mg (three 100 mg delayed-release tablets) starting on the second day of therapy. Merck also markets NOXAFIL (40 mg/mL) oral suspension, which is dosed three times daily.  

NOXAFIL delayed-release tablets and oral suspension are indicated for the 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 hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy. 

“Prophylaxis against invasive Aspergillus and Candida infections plays a key role in the management of severely immunocompromised patients with hematologic malignancies or hematopoietic stem cell transplant recipients who are at high risk for these life-threatening fungal infections," said Daniel Couriel, MD, professor of internal medicine and clinical programme director, adult blood and marrow transplantation program, University of Michigan Comprehensive Cancer Center. “Posaconazole delayed-release tablets offer physicians a way to help protect these critically ill patients against invasive Aspergillus and Candida infections while they are in the hospital and once they return home.”