Anti-Infective Drugs Advisory Committee Meeting

Anti-Infective Drugs Advisory Committee Meeting Committee Meeting November 29, 2012 8:00 a.m. to 5:00 p.m. (Day 2 of 2) Agenda: On November 29, 2012, the committee will discuss new drug application (NDA) 22407, VIBATIV (telavancin hydrochloride) sterile powder for injection, submitted by Theravance, Inc., for the requested indication of nosocomial pneumonia (pneumonia contracted by hospitalized patients), including ventilator-associated pneumonia (VAP), caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-susceptible and –resistant isoloates) or Streptococcus pneumoniae (penicillin susceptible strains).