FDA removes risk evaluation and mitigation strategy (REMS) program
Aug 27, 2025 · The U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) for clozapine (currently marketed as Clozaril, Versacloz, and generics), …
FDA Officially Removes REMS Requirement for Clozapine
Feb 25, 2025 · The FDA will eliminate the REMS program for clozapine, improving access for patients with treatment-resistant schizophrenia. Despite removing REMS, the FDA still advises monitoring …
Clozapine REMS has ended | NCPA
Feb 24, 2025 · Based on an FDA update published in February with little fanfare, the risk evaluation and mitigation strategies (REMS) program for clozapine products has ended effective Feb. 24, 2025.
Although the risk of severe neutropenia with clozapine still exists, FDA has determined that the REMS program for clozapine is no longer necessary to ensure the benefits of the medicine outweigh that risk.
FDA Eliminates the Clozapine REMS—What Comes Next?
Jun 4, 2025 · The now terminated REMS program included "educational efforts" on preventing agranulocytosis. The FDA required all clozapine prescribing physicians in the USA to pass a test on …
ASCP Statement on the Elimination of the Clozapine REMS
Mar 31, 2025 · As of February 24, 2025, the FDA no longer expects prescribers, patients and pharmacists to participate in the risk evaluation and mitigation strategies (REMS) program for …
SMI Adviser and NAMI would like to share important information with clinicians and pharmacists regarding reporting and treatment recommendation updates to the Clozapine Risk Evaluation and …
Clozapine REMS Program Ends Update - Osmind
Mar 5, 2025 · Learn how the end of the Clozapine REMS program impacts prescribing, monitoring, and access for patients with treatment resistant schizophrenia.
Elimination of the clozapine risk evaluation and mitigation strategy ...
Apr 1, 2025 · The FDA has eliminated the clozapine REMS program effective February 2025. This editorial provides an update on clozapine and recognizes that elimination of the clozapine REMS …
FDA is presently working with the clozapine manufacturers to update the prescribing information and eliminate the Clozapine REMS, anticipated to take place in mid-June 2025.