Yesterday, FDA's Anti-Infective Drugs Advisory panel unanimously voted to support approval of two new antibiotics to treat acute skin infections: Sivextro (tedizolid phosphate) and Dalvance (dalbavancin). Although a committee vote does not represent final approval by the FDA, the unanimous committee votes make final approval by the FDA likely. The rising number of durg-resistent infections has put pressure on industry and the FDA to develop and approve newer antibiotics. Both Sivextro and Dalvance were recommended for approval based on a "non-inferiority" process in which approval may be awarded to new antibacterial drugs if the effects are shown to be comparable to an existing approved drug.
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