ARTICLE | Clinical News
FDA panel votes in favor of Paratek's antibiotic
August 10, 2018 4:28 PM UTC
FDA's Antimicrobial Drugs Advisory Committee voted in favor of IV and oral formulations of omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK). The amniomethylcycline antibiotic's PDUFA date is in early October.
The panel voted that there is substantial evidence of the safety and effectiveness of omadacycline 17-1 to treat acute bacterial skin and skin structure infections (ABSSSIs) and 14-4 to treat community-acquired bacterial pneumonia (CABP)...
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