FDA approves omadacycline for treatment of community-acquired bacterial pneumonia


Sumary of FDA approves omadacycline for treatment of community-acquired bacterial pneumonia:

  • The FDA has approved omadacycline, an oral-only dosing regimen, for the treatment of community-acquired bacterial pneumonia, according to a press release from Paratek Pharmaceuticals..
  • Omadacycline (Nuzyra, Paratek Pharmaceuticals) is a novel antibiotic with once-daily oral and IV formulations for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections..
  • “The approval of an oral-only dose regimen for Nuzyra in pneumonia represents a significant opportunity to offer clinicians the ability to treat patients in either the outpatient or primary care setting,”.
  • Omadacycline is a modernized tetracycline designed to overcome tetracycline resistance and exhibit activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative and atypicals including other drug-resistant strains, according to the release..
  • “Treating serious community-acquired infections including pneumonia has become increasingly complex given significant bacterial resistance and major safety concerns seen with older generic antibiotics,”.
  • Nuzyra is contraindicated in patients with hypersensitivity to omadacycline or tetracycline class antibacterial drugs…

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