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 |
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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:
- 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.
- 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.
What assessment is available to the REMS?
Assessment Plan |
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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:
|
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.