Paratek Sees Broad Potential For Omadacycline After Second Phase III Win
Paratek Pharmaceuticals will seek US FDA approval for omadacycline in early 2018 based on a second successful Phase III study for its antibiotic. The company believes the drug has broad potential against multiple pathogens and across multiple patient populations.
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Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.
Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.
US FDA advisory committee will consider "noteworthy" imbalance in deaths in Paratek's trial in community-acquired bacterial pneumonia; agency could not determine cause, briefing documents note.