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News From the Food and Drug Administration
October 1, 2019

New Antibiotic for Community-Acquired Pneumonia

JAMA. 2019;322(13):1246. doi:10.1001/jama.2019.15179

For the first time in more than 15 years, the FDA has approved a systemic antibacterial drug with a novel mechanism of action to combat community-acquired bacterial pneumonia (CABP).

Lefamulin, which is marketed in oral and intravenous (IV) formulations as Xenleta, is indicated for adults with CABP. The drug is a semisynthetic pleuromutilin that inhibits prokaryotic ribosomal protein synthesis through a unique mechanism that reduces its likelihood of developing resistance to bacteria or cross-resistance with the β-lactam, fluoroquinolone, glycopeptide, macrolide, and tetracycline antibiotic classes.