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Approved Risk Evaluation and Mitigation Strategies (REMS)

Lenalidomide
Shared System REMS
REMS last update: 03/24/2023

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Revlimid (Lenalidomide) (Info at Drugs@FDA) NDA 021880 BRISTOL MYERS SQUIBB 05/21/2021
lenalidomide (Info at Drugs@FDA) ANDA 209348 DR REDDYS 08/30/2022
Lenalidomide (Info at Drugs@FDA) ANDA 211022 APOTEX 08/30/2022
Lenalidomide (Info at Drugs@FDA) ANDA 213912 MYLAN 08/30/2022
Lenalidomide (Info at Drugs@FDA) ANDA 210480 LOTUS PHARM CO LTD 08/31/2022
Lenalidomide (Info at Drugs@FDA) ANDA 210435 CIPLA 09/06/2022
Lenalidomide (Info at Drugs@FDA) ANDA 210154 ZYDUS PHARMS 09/12/2022
Lenalidomide (Info at Drugs@FDA) ANDA 211846 SUN PHARM 02/09/2023
Lenalidomide (Info at Drugs@FDA) ANDA 213405 TORRENT 02/17/2023
Lenalidomide (Info at Drugs@FDA) ANDA 214618 CIPLA 03/06/2023
Lenalidomide (Info at Drugs@FDA) ANDA 213885 EUGIA PHARMA 03/06/2023
lenalidomide (Info at Drugs@FDA) ANDA 212414 HETERO LABS LTD V 05/11/2023
lenalidomide (Info at Drugs@FDA) ANDA 217265 QILU 02/22/2024
Lenalidomide (Info at Drugs@FDA) ANDA 201452 ARROW INTL 05/21/2021

What is the purpose of the REMS?

The goals of the Lenalidomide REMS are as follows:

  1. To prevent the risk of embryo-fetal exposure to lenalidomide.
  2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for lenalidomide.

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
03/24/2023 Modified to:
  1. Reflect transfer the Drug Master File (DMF) holder from Celgene Corporation to Bristol- Myers Squibb Company (BMS).
  2. Remove the Celgene logo and references to Celgene, and include administrative updates (e.g., changes to contact department names).
  3. Make editorial changes to the REMS website.
  4. Change the address of the REMS web portal.
08/05/2021 Modified to:
  1. Remove reference to the Prescriber mobile app in the Prescriber Enrollment Form and Prescriber Guide
  2. Update disclosure language and add new checkbox for patients to request Lenalidomide REMS materials in the Patient-Physician Agreement Forms (PPAFs).
  3. Add reference to Patient Companion app in the Pharmacy training, Patient Guide, and REMS Website.
05/21/2021 Approval of the Shared System 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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