Allergan says FDA accepts supplemental new drug application for avycaz
Wednesday, October 12, 2016
FDA accepts supplemental new drug application (SNDA) for avycaz (ceftazidime and avibactam). Allergan plc - FDA is expected to take action on filing in q1 of 2017.
Allergan - application seeks to expand avycaz label to include phase 3 clinical data for treatment of complicated urinary tract infections.
Allergan plc - application included results from a phase 3 study evaluating efficacy and safety of avycaz for treatment of patients with cuti.
Source : reuters.com
