Details Basic Details Status Ongoing Last Updated Friday, March 1, 2024 Original Posting Date Friday, February 24, 2023 Health Outcome(s) acute myocardial infarction (Crohn's disease), acute myocardial infarction (ulcerative colitis), deep vein thrombosis (Crohn's disease), deep vein thrombosis (ulcerative colitis), pulmonary embolism (Crohn's disease), pulmonary embolism (ulcerative colitis), thrombotic stroke (Crohn's disease), thrombotic stroke (ulcerative colitis) Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Regulatory Link(s) (2) Supplement Approval Letter (ulcerative colitis indication) Supplement Approval Letter (Crohn's disease indication)