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...

Read the full 315 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

$35 USD
More Info >