20 November 2018 - Application seeks to expand the Avycaz label to include treatment of cUTI and cIAI in paediatric patients 3 months of age and older.

Allergan today announced that the U.S. FDA has accepted for review the company's supplemental new drug application for Avycaz (ceftazidime and avibactam), seeking to expand the label to include the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), in combination with metronidazole, in paediatric patients 3 months to less than 18 years of age.

The pediatric sNDA is based on two-active control clinical studies evaluating Avycaz in paediatric patients with cIAI or cUTI, as well as a single-dose pharmacokinetic study. In the cIAI study, the safety and efficacy of Avycaz (in combination with metronidazole) was compared with meropenem.

Read Allergan press release