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Description

Fusafungine, also known as fusafungin, is a cyclic depsipeptide antibiotic from Fusarium lateririum used for the treatment of nasal and throat infection including sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis, and tracheitis. Fusafungine consists of a mixture of enniatins and has been widely used over the past 50 years. Its first authorization in the EU was in 1963. Fusafungine showed bacteriostatic activity against a suite of microorganisms, such as Mycoplasma pneumoniae, Legionella pneumophila, Streptococcus pneumoniae, S. pyogenes, and Staphylococcus aureus, including methicillin-resistant S. aureus. Besides its bacteriostatic activity against most micro-organisms involved in respiratory tract infections fusafungine displays original anti-inflammatory properties. Fusafungine has multiple mechanisms of action, including downregulation of the expression of intercellular adhesion molecule-1 (ICAM-1) and inhibition of production of proinflammatory cytokines. In September 2015, an EU-wide assessment of the benefit-risk of fusafungine was initiated due to an increase in the reporting rate of serious allergic reactions. European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended that fusafungine should be withdrawn from the EU market

Approval Year

Substance Class Mixture
Record UNII
65DD690W0C
Record Status Validated (UNII)
Record Version
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Definition References
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