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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Approves New Treatment for Fungal Infections
The Food and Drug Administration approved Eraxis™ (anidulafungin) to treat certain infections caused by Candida, a yeast-like fungus that can cause serious infections in hospitalized patients or patients with compromised immune systems.
"This product offers a new alternative therapy for several types of infections associated with Candida", said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "It is a helpful addition to the available antifungal medications that can be used in the treatment of these potentially serious fungal conditions."
Eraxis, a new molecular entity that has never been marketed in the United States, is an antifungal drug that is administered intravenously, and is used to treat Candida infections in the esophagus (candidiasis), blood stream (candidemia), and other forms of Candida infections, including abdominal abscesses and peritonitis (inflammation of the lining of the abdominal cavity).
The safety and efficacy of Eraxis was evaluated in clinical studies and Eraxis was shown to be safe and effective in the treatment of esophageal candidiasis, candidemia, and other Candida infections including abdominal abscesses and peritonitis.
Eraxis was generally well tolerated in clinical studies. The most commonly reported adverse events were mild diarrhea, mild elevations in laboratory tests of liver enzymes, and headache. Some patients experienced infusion-related reactions, most of which were mild. In a few patients with significant underlying medical conditions who were on multiple concomitant medications, there were reports of serious hepatic abnormalities.
Eraxis is manufactured by Pfizer Inc., New York, NY.