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Mixed recommendation for Actavis' ceftazidime/avibactam
December 6, 2014 3:39 AM UTC
FDA's Anti-Infective Drugs Advisory Committee (AIDAC) recommended approval of ceftazidime/ avibactam ( CAZ-104) from Actavis plc (NYSE:ACT) to treat two forms of complicated infections, but rebuffed the compound's use in other settings in the absence of other options.
On Friday, the panel voted to support the combo's use "when limited or no alternative treatments are available" in two indications: 11-1 for complicated intra-abdominal infections (cIAIs) and 9-3 for complicated urinary tract infections (cUTIs). ...