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AUGUST 10, 2018

FDA Committee Recommends Approval of Omadacycline

By IDSE News Staff

The FDA Antimicrobial Drugs Advisory Committee voted in favor of the approval of IV and oral omadacycline (Paratek Pharmaceuticals) for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP). 

The committee found that the data provided substantial evidence that omadacycline, new class of compounds called aminomethylthylcyclines, related to tetracyclines, which is being developed as a once-daily IV and