Approved Risk Evaluation and Mitigation Strategies (REMS)
Dsuvia (sufentanil)
NDA #209128
REMS last update: 12/19/2023
What is the purpose of the REMS?
The goal of the DSUVIA REMS is to mitigate the risk of respiratory depression resulting from accidental exposure by- ensuring that DSUVIA is dispensed only to patients in certified medically supervised healthcare settings.
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
| Assessment Plan |
|---|
| REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
| Date | Summary of change |
|---|---|
| 12/19/2023 | Changes in the application holder name to reflect transfer of application ownership |
| 04/21/2022 | Modified to make changes to the auditing of healthcare settings to annually audit all certified healthcare settings (or a maximum of 400), that have received at least one shipment of Dsuvia in the past 6 months. |
| 11/02/2018 | Approval of REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.