Details Basic Details Status Ongoing Last Updated Monday, April 15, 2024 Original Posting Date Monday, April 15, 2024 Health Outcome(s) acute myocardial infarction (AMI), 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) FDA Approval Package: Multi-Discipline Review