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Approved Risk Evaluation and Mitigation Strategies (REMS)

Zinbryta (daclizumab)
BLA #761029
REMS last update: 05/01/2018



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
05/01/2018 Application revoked
11/01/2017

Modified to:

  1. Add a secured web-based tool to complete prescriber certification and enrollment and patient enrollment and monitoring online.
  2. Make editorial changes to the REMS document.
  3. Change the REMS materials to conform to the safety labeling changes pertaining to the risks of hepatic injury and immunemediated reactions that were approved on August 28, 2017.
03/10/2017 Revised to make an editorial change and correct a typographical error(s).
05/27/2016 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.

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