FDA approves IV Noxafil for Fungal Infections - Merck

The FDA has approved Noxafil (posaconazole) injection (18 mg/ mL), from Merck, a new formulation of the Fungal Infection treatment for intravenous (IV) use. Noxafil injection is indicated in patients 18 years of age and older. Noxafil delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. With this approval, Merck now provides an IV formulation and two oral formulations of Noxafil for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.

In clinical trials, the adverse reactions reported for Noxafil IV injection were generally similar in type to that reported in trials of oral suspension. The most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing 300 mg once-daily therapy were diarrhea (32%), hypokalemia (22%), fever (21%) and nausea (19%).