Details Basic Details Status Ongoing Last Updated Tuesday, January 17, 2023 Original Posting Date Tuesday, January 17, 2023 Health Outcome(s) acute myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke Purpose Drug and Outcome Analysis Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR No Regulatory Link(s) (1) Supplement Approval Letter