Results Wire: US FDA Advisory Committee Supports Cerexa’s Ceftazidime-avibactam for Complicated Urinary Tract and Complicated Intra-abdominal Infections, But Not for HAVP/BAVP – DEC 5, 2014 (AIDAC)
On Friday, December 5, 2014 the Anti-Infective Drugs Advisory Committee (AIDAC) supported, by a vote of 11-Yes to 1-No, with no abstentions, the safety and efficacy of ceftazidime-avibactam for injection, submitted by Cerexa Inc., for the proposed indication of Complicated Intra-abdominal Infections (cIAI), when limited or no alternative treatments are available.
The committee supported, by a vote of 9-Yes to 3-No, with no abstentions, the safety and efficacy of ceftazidime-avibactam for injection for the Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis, when limited or no alternative treatments are available.
The committee unanimously did not support, by a vote of 0-Yes to 12-No, with no abstentions, the safety and efficacy of ceftazidime-avibactam for a limited use indication: Aerobic Gram-negative Infections with Limited Treatment Options, when limited or no alternative treatments are available.
The committee did not support, by a vote of 1-Yes to 11-No, with no abstentions, the safety and efficacy of ceftazidime-avibactam for a limited use indication: Aerobic Gram-negative Infections with No Treatment Options, when no alternative treatments are available.