5:56 PM
 | 
Nov 27, 2012
 |  BC Extra  |  Company News

FDA reviewers question Vibativ efficacy, safety

FDA reviewers outlined safety concerns and trial design issues identified in a resubmitted NDA for Vibativ telavancin from Theravance Inc. (NASDAQ:THRX) to treat nosocomial pneumonia (NP), including ventilator-associated pneumonia known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA). In briefing documents released ahead of FDA's Anti-Infective Drugs Advisory Committee Thursday meeting to discuss the NDA, the reviewers questioned "inconsistencies" in clinical...

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