FDA Updates Approved REMS

Published on: 

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.


FDA has updated its approved Risk Evaluation and Mitigation Strategies (REMS). FDA requires REMS from manufacturers to ensure that the potential risks posed by drug products are outweighed by the benefits to patient health.


Products affected by the updates to the approved REMS include:

  • Xeljianz (tofacitinib) tablets

  • Buprenorphine Transmucosal Products for Opioid Dependence (BTOD) 

  • Extended-Release and Long-Acting Opioid Analgesics REMS  

  • Mycophenolate REMS

  • Rosiglitazone REMS 

  • Transmucosal Immediate-Release Fentanyl (TIRF) Products

More information can be found at FDA.gov.