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FDA panel to review Paratek antibiotic

June 20, 2018 7:50 PM UTC

FDA's Antimicrobial Drugs Advisory Committee has scheduled an Aug. 8 meeting to discuss two NDAs for omadacycline from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK).

The agency is reviewing oral and IV versions of the amniomethylcycline antibiotic to treat community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). The PDUFA date is in early October...