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Widespread Off-Label Use Could Ensure Injectable Bacitracin's Future

Executive Summary

US FDA advisory committee will weigh fate of the injectable antibiotic, which can cause renal failure and is only approved for treatment of pediatric pneumonia. However, its real-world use is almost entirely in the surgical setting for irrigation and prophylaxis. Xellia, one of five companies that markets the generic drug, said the risk/benefit profile for on-label use remains positive and evidence on off-label use warrants further exploration.

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