On May 21, 2021, the Food and Drug Administration (FDA) approved a generic lenalidomide product. This approval will trigger the transition of REVLIMID REMS® to the Lenalidomide REMS Shared System approved by FDA in September 2020. Generic lenalidomide is not yet commercially available, but will become available through Lenalidomide REMS on March 03, 2022.

A transition period is in place for the approved Lenalidomide REMS:

  • Before August 16, 2021, REVLIMID REMS prescribers, patients, and pharmacies will continue using REVLIMID REMS to complete REMS activities.
  • Starting August 16, 2021, Lenalidomide REMS will replace REVLIMID REMS and be used to complete REMS activities.
  • REVLIMID REMS prescribers and patients will be able to participate in the Lenalidomide REMS without further actions. Certified pharmacies will be contacted for training.
  • Please contact Lenalidomide REMS at 1-888-423-5436 with any questions.


REMS administered by:

The Lenalidomide REMS includes both REVLIMID® (lenalidomide) and generic lenalidomide products. The Lenalidomide Manufacturers have a contractual agreement under which Celgene Corporation administers the REMS on behalf of the Lenalidomide Manufacturers. All manufacturers retain the responsibility for the actions described in the REMS.

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On May 16, 2020, the Food and Drug Administration (FDA) approved generic thalidomide and Thalidomide REMS. Generic thalidomide is not yet commercially available, but will become available through Thalidomide REMS on June 15, 2020.

A transition period is in place for the approved Thalidomide REMS:

  • Before June 15, 2020, THALOMID REMS® prescribers, patients and pharmacies will continue using THALOMID REMS to complete REMS activities.
  • Starting June 15, 2020, Thalidomide REMS will replace THALOMID REMS and be used to complete REMS activities.
  • THALOMID REMS prescribers and patients will be able to participate in the Thalidomide REMS without further action. Certified pharmacies will be contacted for training.
  • Please contact Thalidomide REMS at 1-888-423-5436 with any questions.


REMS administered by:

The Thalidomide REMS includes both THALOMID® (thalidomide) and generic thalidomide products. The Thalidomide Manufacturers have a contractual agreement under which Celgene Corporation administers the REMS on behalf of the Thalidomide Manufacturers. All manufacturers retain the responsibility for the actions described in the REMS.

I acknowledge this.
 
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