Allergan Files SNDA To Expand AVYCAZ Label - Quick Facts

(RTTNews) - Allergan plc (AGN) announced the U.S. FDA has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ, seeking the addition of new Phase 3 clinical trial data evaluating AVYCAZ in patients with complicated urinary tract infections, including pyelonephritis, due to designated susceptible pathogens to the current product label.

Allergan said the FDA has granted priority review status to the sNDA application based on the previous QIDP designation for AVYCAZ and is expected to take action on the filing in the first quarter of 2017.