FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
Paratek Pharmaceuticals, Inc. (PRTK)
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Source: GlobeNewswire
-- Positive vote for both the skin infections and pneumonia indications -- -- FDA decision expected in early October 2018 -- BOSTON, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the Antimicrobials Drug Advisory Committee of the U.S. Food and Drug Administration voted in favor of the approval of intravenous (IV) and oral omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) (17-1) and community-acquired bacterial pneumonia (CABP) (14-4). Omadacycline is a modernized tetracycline being developed as a once-daily IV and oral, broad spectrum antibiotic for the treatment of serious community-acquired infections. “Omadacycline has the potential to help address the urgent and growing need for new antibiotics to treat serious community-acquired infections. With once-daily dosing and bioequivalent IV and oral formulations, omadacycline may help facilitate early discharge from the hospital or, in
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