Details Basic Details Approval Date Friday, October 18, 2019 Original Posting Date Monday, October 17, 2022 Health Outcome(s) malignancy (ulcerative colitis), serious infection (ulcerative colitis) Regulatory Link(s) (1) FDA Supplement Approval and ARIA Memo Link(s) Sentinel Drug Study: Stelara (Ustekinumab) & Serious Infection