Details Basic Details Status Ongoing Last Updated Wednesday, August 23, 2017 Health Outcome(s) serious infection Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR Yes Result(s) (2) Ustekinumab Dispensing Patterns: A Descriptive Analysis Serious Infection Following Ustekinumab Use in Patients with Crohn’s Disease or Ulcerative Colitis: A Descriptive Analysis Regulatory Link(s) (1) Supplemental Approval Letter