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Approved Risk Evaluation and Mitigation Strategies (REMS)

Vigabatrin
Shared System REMS
REMS last update: 10/12/2022

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Sabril (vigabatrin) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 020427 LUNDBECK PHARMS LLC 04/27/2017 a5d389d2-d0e1-4395-a2a2-b552808e7f98 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=020427
Sabril (vigabatrin) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 022006 LUNDBECK PHARMS LLC 04/27/2017 a88ac1b4-e2c9-45c0-b321-4785902172e3 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022006
vigabatrin (vigabatrin) (Info at Drugs@FDA) ANDA 215363 MSN 09/07/2022
Vigadrone (vigabatrin) (Info at Drugs@FDA) ANDA 214749 UPSHER SMITH LABS 06/29/2023
Vigadrone (vigabatrin) (Info at Drugs@FDA) ANDA 210196 AUCTA 06/21/2018
vigabatrin (Info at Drugs@FDA) ANDA 211481 DR REDDYS 11/20/2018
vigabatrin (Info at Drugs@FDA) ANDA 209822 TEVA PHARMS USA 01/14/2019
vigabatrin (Info at Drugs@FDA) ANDA 211592 INVAGEN PHARMS 12/03/2019
vigabatrin (Info at Drugs@FDA) ANDA 213469 GRANULES 04/24/2020
vigabatrin (Info at Drugs@FDA) ANDA 214425 ACCORD HLTHCARE 11/13/2020
vigabatrin (Info at Drugs@FDA) ANDA 213375 ALKEM LABS LTD 12/02/2020
vigabatrin (Info at Drugs@FDA) ANDA 213519 ANNORA PHARMA 01/27/2021
vigabatrin (Info at Drugs@FDA) ANDA 211539 DR REDDYS 01/29/2021
vigabatrin (Info at Drugs@FDA) ANDA 214992 DEXCEL 05/13/2021
vigabatrin (Info at Drugs@FDA) ANDA 212626 SPECGX LLC 07/28/2021
vigabatrin (Info at Drugs@FDA) ANDA 213390 PROPEL PHARMA 07/29/2021
vigabatrin (Info at Drugs@FDA) ANDA 215109 DEXCEL 09/23/2021
vigabatrin (Info at Drugs@FDA) ANDA 213899 AUROBINDO PHARMA LTD 09/29/2021
vigabatrin (Info at Drugs@FDA) ANDA 215707 ZYDUS LIFESCIENCES 01/19/2022
vigabatrin (Info at Drugs@FDA) ANDA 211790 CHARTWELL RX 03/10/2022
vigabatrin (Info at Drugs@FDA) ANDA 215601 AUROBINDO PHARMA LTD 05/10/2022
vigabatrin (Info at Drugs@FDA) ANDA 210042 AMNEAL PHARMS 06/22/2022
vigabatrin (Info at Drugs@FDA) ANDA 214961 PYROS PHARMS 06/24/2022
vigabatrin (Info at Drugs@FDA) ANDA 213104 HIKMA 08/29/2022
vigabatrin (Info at Drugs@FDA) ANDA 214617 03/01/2023
vigabatrin (Info at Drugs@FDA) ANDA 215519 PROPEL PHARMA 04/28/2023
vigabatrin ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 208218 ENDO OPERATIONS 04/27/2017 e7cbc0a5-8c28-4451-9176-b608e228ba66
vigabatrin (Info at Drugs@FDA) ANDA 210155 AMNEAL PHARMS 03/13/2018
vigabatrin (Info at Drugs@FDA) ANDA 209824 TEVA PHARMS USA 04/24/2018

What is the purpose of the REMS?

The goal of the Vigabatrin REMS Program is to mitigate the risk of vision loss associated with vigabatrin by:

  1. Ensuring that healthcare providers are educated about the risk of vision loss, the need to counsel patients about the risk, and the need for periodic visual monitoring.
  2. Ensuring that vigabatrin is only dispensed to patients with documentation that patients are informed about the risk of vision loss associated with vigabatrin and the need for periodic visual monitoring.

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

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
10/12/2022

Modified to:

  1. Change the timetable for submitting REMS assessments to every two years, rather than annually, beginning with the next REMS assessment due on April 27, 2022, and the following assessment on April 27, 2024.
  2. Update the REMS materials to align with the labeling approved on October 20, 2021.
10/02/2020 Modified to make REMS Document revisions to accurately reflect stakeholder requirements and REMS operations and updates to the REMS Program website screenshots, including removal of a pop-up on the landing page and addition of a verification history function.
01/24/2020 Modified to make changes to the REMS materials to reflect the revised age range for the rCPS indication. The Prescriber Enrollment and Agreement Form, Patient Guide, and REMS Website have been revised to align with the revised age range for the rCPS indication.
09/12/2019 Modified to make changes to the nonpublic REMS website screenshots for the inpatient pharmacy REMS verification process.
05/30/2019 Modified to allow for the continuation of therapy for patients currently enrolled in the Vigabatrin REMS by an uncertified prescriber in the inpatient setting, and incorporating the requirement that a certified prescriber must authorize additional vigabatrin dispenses for these patients within 15 days of inpatient admission. The REMS document and Pharmacy Enrollment Form were revised to align with these changes. The REMS document was also revised to align with the Format and Content of a REMS Document Guidance for Industry.
10/23/2017 Modified to make changes to the website screenshots that include the addition of language that will prevent the need for a REMS modification each time an ANDA is added and/or removed from the REMS, and/or a pharmacy is added to, or removed from the list of certified pharmacies.
05/24/2017 Revised to make an editorial change.
04/27/2017 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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