Allergan (AGN) Announces FDA Accepts sNDA for AVYCAZ
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FDA Accepts Supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam)
October 11, 2016 8:01 AM EDTDUBLIN, Oct. 11, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), seeking the addition of new Phase 3 clinical trial data evaluating AVYCAZ in patients with complicated urinary tract infections (cUTI), including pyelonephritis, due to designated susceptible pathogens to the current product label. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP)... More
