Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA

— PDUFA Action Date in October 2018 —
BOSTON, April 04, 2018 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for omadacycline, an investigational once-daily oral and intravenous (IV) broad spectrum antibiotic. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The two NDAs were granted priority review based on the significant unmet medical need for new agents to treat ABSSSI and CAB…

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