Details Basic Details Approval Date Wednesday, February 1, 2023 Original Posting Date Friday, March 15, 2024 Health Outcome(s) adverse pregnancy and fetal outcomes, gastrointestinal (GI) bleed, heart failure, major adverse cardiovascular events, malignancy, retinopathy proliferative, venous thromboembolism (VTE) Regulatory Link(s) (2) FDA Approval Package ARIA Memo