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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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Paratek Pharmaceuticals Inc.