Allergan: FDA To Review SNDA Filing For AVYCAZ - Quick Facts

(RTTNews) - Allergan plc (AGN) announced the U.S. FDA has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ (ceftazidime and avibactam), seeking to expand the label to include the treatment of complicated urinary tract infections and complicated intra-abdominal infections, in combination with metronidazole, in pediatric patients 3 months to less than 18 years of age.

AVYCAZ was first approved by the FDA in February 2015 for the treatment of cUTI including pyelonephritis, and cIAI in combination with metronidazole, caused by designated susceptible bacteria including certain Enterobacteriaceae and Pseudomonas aeruginosa, for patients 18 years of age and older. AVYCAZ was subsequently approved for the treatment of adults with hospital-acquired pneumonia/ventilator-associated pneumonia (HABP/VABP) caused by designated susceptible bacteria in February 2018.