Details Basic Details Status Ongoing Last Updated Tuesday, May 17, 2022 Health Outcome(s) serious infection (Crohn’s disease), serious infection (ulcerative colitis) 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) FDA Approval Package Materials