FDA advisory panel backs Actavis' ceftazidime-avibactam

Ireland-headquartered generic drugs major Actavis (NYSE: ACT) says that the Anti-Infective Drugs Advisory Committee convened by the US Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam.

This is an investigational antibiotic being developed to treat hospitalized patients when limited or no treatment options are available for complicated intra-abdominal infections (cIAI) (in combination with metronidazole) and complicated urinary tract infections (cUTI) (including acute pyelonephritis) caused by Gram-negative pathogens.

The committee found the scientific and clinical evidence submitted by Cerexa, a wholly-owned subsidiary of Actavis, adequately demonstrated the safety and efficacy of ceftazidime-avibactam in the treatment of the proposed cIAI and cUTI indications.