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In the context of Omadacycline & Community-acquired bacterial pneumonia (CABP), Omadacycline received U.S. FDA approval in October 2018 for two indications: community‑acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults (1, 2, 3). Pharmacokinetic and PK/PD analyses consistently describe omadacycline as “approved in the United States to treat patients with community‑acquired bacterial pneumonia (CABP),” confirming CABP as a formal labeled indication (3, 4).
The randomized clinical phase III treatment trial NCT02531438 revealed that Omadacyc…