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Efficacy and safety of generic amphotericin B in experimental pulmonary aspergillosis
Authors:Petraitis Vidmantas  Petraitiene Ruta  Lin Pengxin  Calis Karim  Kelaher Amy M  Muray Heidi A  Mya-San Christine  Mickiene Diana  Bacher John  Walsh Thomas J
Affiliation:Immunocompromised Host Section, Pediatric Oncology Branch, National Cancer Institute, Building 10, CRC, Rm. 1W-5740, 10 Center Dr., MSC 1100, Bethesda, Maryland 20892-1100, USA.
Abstract:The recent shortage of the brand name drug Fungizone has necessitated a change to generic formulations of amphotericin B deoxycholate. Clinical trials cannot be conducted in a timely manner to provide data on the safety and efficacy of these formulations. We therefore compared generic amphotericin B and Fungizone for activity and safety in the treatment of experimental invasive pulmonary aspergillosis (IPA) in persistently neutropenic rabbits. Fungizone and generic amphotericin B are similar in efficacy, pharmacokinetics, and safety in the treatment of experimental IPA.
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