Theravance's Vibativ gains partial support from FDA panel

12/3/2012 | American City Business Journals

An FDA advisory panel endorsed the approval of Theravance's once-daily antibiotic Vibativ to treat patients with hospital-acquired pneumonia when other alternatives are not suitable. But the drug failed to win the advisory committee's approval recommendation as a first-line therapy for the condition, also known as nosocomial pneumonia. Trial data failed to offer "substantial evidence" of Vibativ's safety and efficacy against hospital-acquired pneumonia, the panel said.

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