Theravance Offers FDA Briefing Documents for Panel Meeting on VIBATIV(R)
Theravance, Inc. (NASDAQ: THRX) today announced that the US FDA has posted on its website briefing documents for the November 29, 2012 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. The AIDAC will be asked to review and discuss Theravance's New Drug Application (NDA) for VIBATIV(R) (telavancin), a bactericidal, once-daily injectable antibiotic, for the proposed indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) or Streptococcus pneumonia (penicillin susceptible strains). The Theravance Briefing Document and the FDA Briefing Document are now available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti- InfectiveDrugsAdvisoryCommittee/ucm329476.htm.
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