FDA approves Avycaz for cUTIs and cIAI

FDA approved an NDA for Avycaz ceftazidime/avibactam from Actavis plc (NYSE:ACT) to treat complicated urinary tract infections (cUTIs) and in combination with metronidazole to treat complicated intra-abdominal infections (cIAIs), both of which are caused by Gram-negative pathogens. FDA said the drug should be limited to patients who have few or no alternative treatment options. Actavis plans to launch Avycaz in the second quarter.

The product is a combination of the third-generation cephalosporin ceftazidime and avibactam, which is a broad-spectrum beta lactamase ( LACTB) inhibitor. Avycaz has Qualified Infectious Disease Product (QIDP) designation and was under Priority Review. ...