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Antimicrobial Drugs Advisory Committee

On Friday, April 26, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) met to discuss the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is its only approved indication. a

A majority of the committee, 17 of 18 members, voted that the benefits of bacitracin for intramuscular injection do not outweigh the risks for its approved indication of the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. One committee member abstained from voting.

The committee also gave input on potential uses for bacitracin for intramuscular injection that could be studied.