U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. REMS

Approved Risk Evaluation and Mitigation Strategies (REMS)


Shared System REMS
REMS last update:

What is the purpose of the REMS?

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.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
03/08/2016
11/25/2015 Modified to add an authorized generic to the existing REMS.
07/08/2015 Modified to

  1. remove from the REMS document and appended materials:
    1. the requirement for certified pharmacies to utilize a Tikosyn stamp
    2. all references to the Tikosyn stamp
    3. the phrase “…and dispensed for use only with documentation of safe use conditions”
  2. clarify that the one-time recertification of prescribers and dispensers was required only after initial approval of the REMS in the REMS document
12/06/2013 Modified to include information about the risk of increased exposure of Tikosyn (dofetilide) when administered concomitantly with Tivicay (dolutegravir) in the Medication Guide, treatment guidelines, REMS website, and the TIPS Procedure Booklet.
07/11/2011 Approval of the 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.

Back to Top