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Approved Risk Evaluation and Mitigation Strategies (REMS)

Shared System REMS
REMS last update: 03/23/2023

*Other Important Information from FDA

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Mifeprex (mifepristone) (Info at Drugs@FDA) NDA 020687 DANCO LABS LLC 04/11/2019
mifepristone (Info at Drugs@FDA) ANDA 091178 GENBIOPRO 04/11/2019

What is the purpose of the REMS?

The goal of the REMS for mifepristone is to mitigate the risk of serious complications associated with mifepristone by:
  1. Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone REMS Program.
  2. Ensuring that mifepristone is only dispensed by or under the supervision of certified prescribers, or by certified pharmacies on prescriptions issued by certified prescribers.
  3. Informing patients about the risk of serious complications associated with mifepristone.

What do participants need to know?

For a general overview of the REMS for all REMS participants (e.g., healthcare providers, patients, and pharmacies ) refer to the REMS document under the REMS Material tab above.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Mifepristone REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Patient Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Patient_Agreement_Form.pdf
Pharmacy Agreement Form for Danco Laboratories, LLC (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Pharmacy_Agreement_Form _for_Danco_Laboratories_LLC.pdf
Pharmacy Agreement Form for GenBioPro, Inc. (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Pharmacy_Agreement_Form_for_GenBioPro_Inc..pdf
Prescriber Agreement Form for Danco Laboratories, LLC (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Prescriber_Agreement_Form_for_Danco_Laboratories_LLC.pdf
Prescriber Agreement Form for GenBioPro, Inc. (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_Prescriber_Agreement_Form_for_GenBioPro_Inc..pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_03_23_REMS_Full.pdf

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
03/23/2023 Modified to revise the Prescriber Agreement Forms to add space to allow for additional contact information on the forms, as well as a revision to the GenBioPro, Inc. Prescriber Agreement Form to correct a typographical error.
01/03/2023 Modified according to the letter dated December 16, 2021. In addition, modified to:
  • Revise the REMS goal to align with the updated REMS requirements.
  • Replace serial number with recording of NDC and lot number of mifepristone dispensed.
  • Make additional edits for clarification and consistency in the REMS Document and REMS materials (Prescriber Agreement Forms, Patient Agreement Form, and Pharmacy Agreement Forms).
  • 05/14/2021 Modified to revise the Patient Agreement Form to include gender neutral language and minor revisions to the REMS document to be consistent with the revisions to the Patient Agreement Form.
    04/11/2019 Modified to establish a SSS REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Mifeprex and ANDAs referencing Mifeprex, called the Mifepristone REMS Program.

    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.

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