ARTICLE | Company News
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...