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FDAnews Drug Daily Bulletin
Nov. 6, 2012 | Vol. 9 No. 218
AIDAC Recommends Approval of GSK’s Anti-Anthrax Drug on Resubmission
The FDA’s Anti-Infective Drugs Advisory Committee Friday recommended approval of GlaxoSmithKline’s (GSK) 40-mg/kg raxibacumab IV solution, with or without an antimicrobial, to treat adults infected in an airborne anthrax attack. The committee voted 16 to 1 in favor of the drug, with one abstention. All panelists agreed GSK’s animal studies had shown efficacy but one member was concerned the drug’s effect was not proven statistically significant.
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